Specialty Portfolio Update: March 2023 - Prime Therapeutics LLC (2023)


March 27, 2023

This monthly project overview provides an overview of newly approved specialty drugs, recently launched specialty drugs, new indications, and important news about specialty drugs in the approval process. More information on piping can be found in separate articles.traditionaldrugs,BiosimilaresYgene/cellTherapy.

Information about new drugs

  • Altuviiio®[antihemophilic factor (recombinant), Fc-VWF-XTEN-ehtl fusion protein]:The United States The Food and Drug Administration (FDA) has approved Sanofi's Altuviiio, a first-in-class long-acting factor VIII replacement therapy. Altuviiio is indicated for routine prophylaxis and reliever treatment to control bleeding episodes, and for perioperative treatment (surgery) in adults and children with hemophilia A. Altuviiio is the first treatment for hemophilia A that produces hemophilia A activity levels factor VIII normal or near normal (greater than 40%) for most of the week when given once weekly and significantly reduces bleeding compared with prior factor VIII prophylaxis. The FDA approval was based on the Phase 3 XTEND-1 clinical trial, which showed that once-weekly Altuviiio prophylaxis met the primary endpoint of providing significant protection against bleeding for people with severe hemophilia A with a mean annual bleeding rate (ABR) of 0.70 and a mean achieved ABR of 0.0.1Altuviiio is expected to be commercially available in April at a price equivalent to the annual cost of treating one prophylactic patient with Eloctate®that's $12 per unit, or a cost of $12,000 for a patient requiring 1,000 IU per week, or $625,000 per year.2
  • Skyclarys™ (Omaveloxolona):The FDA has approved Reata Pharmaceuticals' Skyclarys for the treatment of Friedreich's ataxia in adults and adolescents 16 years of age and older. Friedreich's ataxia is a rare, genetically determined neurodegenerative disease. Patients with Friedreich's ataxia usually present with symptoms in childhood, including progressive loss of coordination, muscle weakness, and fatigue. About 5,000 patients in the United States are currently diagnosed with Friedreich's ataxia. Skyclarys was approved based on a clinical study showing that patients treated with Skyclarys had a statistically significantly lower score on the Modified Friedreich Ataxia Rating Scale (mFARS) at week 48 compared to placebo, representing a placebo-corrected difference between groups of -2.41 points.3Skyclarys is available in 50mg capsules. Skyclarys has entered the market with an average wholesale price (AWP) of $37,000 per bottle (90 capsules).
  • Daybue®(Trophiniden): The FDA approved Daybue from Acadia Pharmaceuticals for the treatment of Rett syndrome in adult and pediatric patients two years of age and older. Daybue is the first drug approved by the FDA for Rett syndrome. Rett syndrome is caused by a genetic mutation in which patients develop normally during childhood but later deteriorate and lose speech, hand motor control, and other functions. There are approximately 4,500 patients diagnosed with Rett syndrome in the United States. Daybue is a twice-daily solution that reduces inflammation in the brain, prevents certain types of cells from becoming overactive, and increases levels of a natural protein called IGF-1. Daybue was approved based on a phase 3 lavender study that showed that treatment with Daybue improved patients' symptoms compared to placebo in two questionnaire rating systems.4Patients reported consistent benefits. Daybue is expected to be available in late April at an average list price of approximately $575,000 to $595,000 per year, or $21.10 per milliliter for weight-based dosing.

new indications

  • Version®(abemaciclib): The FDA has approved an expanded indication for Lilly's Verzenio in combination with endocrine therapy (ET) for the adjuvant treatment of adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative mammary nodes. -). early stage cancer (EBC) with high risk of recurrence. High-risk patients eligible for Verzenio can now be identified solely on the basis of node status, tumor size, and tumor grade (4+ nodes positive or 1-3 nodes positive and at least one of the following: 5 cm in size or grade 3 ). This expanded adjunctive indication eliminates the Ki-67 score requirement for patient selection.
  • Kevzara®(sarilumab):The FDA has expanded the indication for Sanofi's Kevzara and Regeneron to include the treatment of adults with polymyalgia rheumatica (PMR) who have had an inadequate response to corticosteroids or who are intolerant of corticosteroid dose reductions.
  • jelly®(including limb-gxly): The FDA has granted GlaxoSmithKline (Tesaro) and Jemperli of AnaptysBio a transition from accelerated to full approval with a revised indication for the treatment of patients with advanced or recurrent endometrial cancer due to mismatch repair (dMMR) deficiency ), as determined by an FDA-approved test to have progressed on or after platinum-based therapies and are not candidates for curative surgery or radiation.

march news

  • “A sudden change of heart at the FDA has caused Sarepta Therapeutics shares to plummet. Sarepta did so two weeks after announcing that the FDA would evaluate its gene therapy without an advisory committee meeting.revealedThe agency will now convene experts to review data on his presentation of Duchenne muscular dystrophy (DMD). Late last month, Sarepta informed investors that it had completed the mid-cycle review for the SRP-9001 submission, and while no significant clinical or safety issues emerged, the FDA had decided to proceed without an advisory committee meeting. . The decision triggered a jump in Sarepta's share price and put the company on track to potentially receive regulatory approval before May 29 without undergoing independent peer review."5
  • “BioMarin Pharmaceutical Inc. announced that it has received notification from the FDA that the agency has expanded the review of the company's Biologics License Application (BLA) for the Roctavian™ (valoctocogene roxaparvovec) gene therapy for adults with hemophilia A. serious. The FDA has determined that the submission of the three-year data analysis from the ongoing Phase 3 GENEr8-1 study represented a significant change due to the significant amount of additional data and established a new PDUFA target action date of January 30. June 2023. The company previously advised that this data transfer could qualify as a material amendment.”6
  • “Ahead of the advisory committee hearing to discuss Biogen's ALS drug Tofersen, the FDA expressed its willingness to approve the drug, recently released briefing papers show. Noting the need for flexibility in a devastating disease like ALS, regulators signaled their willingness to give Tofersen the green light despite the failure of a pivotal study due to its effects on a specific protein implicated in ALS. The documents come after the regulatory flexibility was part of the same rationale the agency expressed in approving an ALS drug from Amylyx Pharmaceuticals last September, signaling the FDA's openness to approving new treatments for the disease. "Despite the notable limitations of a failed study and the many post-hoc exploratory analyzes performed after [the Phase III study], the department believes that the data could indicate a treatment effect of Tofersen on SOD1-ALS," he wrote. the fda. “This is a very rare and devastating disease; It is therefore paramount that we fully consider all available data." Tofersen did not achieve the primary endpoint of his phase 3 VALUE study because he was unable to show that it was better at delaying decline in function in patients with ALS SOD1 than placebo The results, reported in October 2021, showed that the observable effect of the drug on function was most likely due to chance that Tofersen achieved the desired result.Biogen said the p-value for the primary endpoint was p = 0.97".7
  • "The FDA is working to expedite gene therapy development, including promoting the use of biomarkers to achieve accelerated approval of therapies for serious diseases," an agency official said. Biomarkers such as heart rate and blood pressure are characteristics of the body that can be measured. The FDA will support the use of biomarkers as surrogates for other biological markers in gene therapy clinical trials to achieve "expedited approval," said the agency's Peter Marks.8


  1. https://www.sanofi.com/es/sala-de-prensa/comunicados-de-prensa/2023/2023-02-23-21-00-00-2614759
  2. https://www.sanofi.com/es/sala-de-prensa/comunicados-de-prensa/2023/2023-02-23-21-00-00-2614759
  3. https://www.neurologylive.com/view/fda-aprueba-omaveloxolona-primer-tratamiento-friedreich-ataxie
  4. https://www.rettsyndrome.org/trofinetideapproved/
  5. https://www.fiercebiotech.com/biotech/fda-shocks-sarepta-ordering-adcomm-dmd-gene-therapy-sudden-change-heart
  6. https://investors.biomarin.com/2023-03-06-BioMarin-offers-Update-on-FDA-Review-of-ROCTAVIAN-TM-Valoctocogene-Roxaparvovec-Gene-Therapy-for-Adults-with-Severe- Hemophilia-A
  7. https://endpts.com/fda-indicates-willingness-to-approve-biogen-als-drug-pese-failed-phiiii-study/
  8. https://www.reuters.com/world/us/us-fda-official-says-agency-needs-start-using-accelerated-approval-gene-2023-03-20/
Specific new product approvals in the last 12 months
generic namebrand nameManufacturerIndicationsform of administrationapproved month
trophinétidosDaybue®Acadia Pharmaceuticals Inc.syndrome of the rightOralMarch 2023
Good luckSkyclarys™pharmaceutical feeAtaxia de FriedreichOralFebruary 2023
signrabenazinaAustedo™ XRTevaTardive dyskinesia and chorea associated with Huntington's diseaseOralFebruary 2023
Antihemophilic factor (recombinant), Fc-VWF-XTEN-ehtl fusion proteinAltuvio™Sanofi/Sobihemophilia AIVFebruary 2023
thriftyFilspariTravere-TherapeuticsIgA Nephropathy (IgAN)OralFebruary 2023
velmanasa alphaLamazede™Chiesi Global Rare Diseasesalpha-manocidoseIVFebruary 2023
pegcetacoplanSyfovre™Apellis PharmaGeographic atrophy secondary to DMAEintravitrealFebruary 2023
daprodustatJesduvroq™ TabletsGlaxoSmithKlineOral treatment of anemia due to chronic kidney diseaseOralFebruary 2023
Lecanemab-irmbThis Team™EisaiAlzheimer diseaseIVJanuary 2023
Anakaurasa-bcdbNexoBrid™MediWoundburn tissueTopical GelJanuary 2023
sodium phenylbutyrateOlpruv™Acer Therapeutics/ Relief TherapeuticsUrea cycle disordersOralJanuary 2023
Ublituximab-xiiyBriumvi™TG-Therapeuticarecurrent multiple sclerosisIVDecember 2022
Faekale Microbiota, Live-jslmRebyota™Ferring (Rebiotix)Clostridioides difficileRectalNovember 2022
teplizumab-mzwvTzield™organic prophylaxisDelay certain forms of diabetesIVNovember 2022
furosemideFuroscix™ScPharmaceuticalsDiuresis in patients with worsening heart failureMinibomba SCOctober 2022
sodium phenylbutyrate and taurursodiolRelyvrio™Amylyx Pharmaceuticals Inc.Amyotrophic Lateral Skeleton (ALS)OralSeptember 2022
eflapegrastim-xnstRolfedon®Spectrum Pharmaceuticals/ Hanmi PharmaceuticalsChemotherapy-induced neutropeniaSOUTH CAROLINASeptember 2022
sodium thiosulfatePedmark™Fennek-ArzneimittelPrevention of cisplatin-induced ototoxicityIVSeptember 2022
terlipresinaTerlivaz®malinckrodtImprovement of renal function in adults with hepatorenal syndrome (HRS)SOUTH CAROLINASeptember 2022
deucravacitinibThey will meet®bristol myers squibbplaque psoriasisOralSeptember 2022
Spesolimab-sbzosuffocation®Boehringer IngelheimFlare-ups of generalized pustular psoriasis (GPP)IVSeptember 2022
Olipudasa alfa-rpcpXenpozym®SanofiAcid sphingomyelinase deficiencyIVAugust 2022
sodium oxybateLumryz™

Provisional Approval

Avadel PharmanarcolepsyOraljulio 2022
on vutrisiraAmwuttra®Alnylam PharmaceuticalsHereditary transthyretin-mediated amyloidosis polyneuropathy (hATTR)SOUTH CAROLINAJune 2022
EdaravonLived in the ORS®Mitsubishi Tanabe PharmaAmyotrophic Lateral Skeleton (ALS)Oralmayo 2022
TrientintetraclorhidratoCuvrior™orphanmorbus wilsonOralmayo 2022
Treprostinil dry powder for inhalationTwenty DPI®United Therapeutic CorporationNew dry powder formulation for the treatment of pulmonary arterial hypertensioninhaledmayo 2022
mavacamténCamzyos®Bristol-Myers SquibbSymptomatic Hypertrophic Obstructive Cardiomyopathy (HoMC)OralApril 2022
New indications for approved specialty products
(Video) Inflation Outlook | Bloomberg Surveillance 03/27/2023
generic namebrand nameManufacturerNew indication(s)Approval date
SelfishKevzara®Sanofi/RegeneronPolymyalgia rheumatica (PMR) who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid reductionFebruary 2023
afliberceptEylea®Regeneronretinopathy of prematurityFebruary 2023
abrocitinibCimbaqo®PfizerAdolescents (12 to <18 years) with refractory moderate to severe atopic dermatitis (AD) that is not adequately controlled with other systemic products, including biologics, or when these therapies are not recommendedFebruary 2023
Lanadelumab-FlyoTakhziro®countyExpanded pediatric prophylactic indication to prevent hereditary angioedema (HAE) attacks in children 2 to <12 years of ageFebruary 2023
Tezepelumab-ekkoTezspire®AstraZeneca/Amgensevere asthmaFebruary 2023
tocilizumabActemra®IVGenentech (Roche)COVID-19 in hospitalized adults receiving systemic corticosteroids and requiring supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).December 2022
concussion devicesbe quiet®radius healthMen with osteoporosis at high risk of fractureDecember 2022
Tildrakizumab-asmnIlumya®Sonne/ Merck & Co.plaque psoriasis of the scalpDecember 2022
UpadacitinibRenew®AbbVieNon-radiographic active axial spondyloarthritis (nr-axSpA) with objective evidence of inflammation that has not responded adequately to NSAIDsOctober 2022
lubricateOxlumo®AlnylamPrimary hyperoxaluria type 1 (PH1) involves reduced plasma oxalate in patients with advanced PH1, including patients with end-stage renal disease on dialysisOctober 2022
dupilumabduplicity®Sanofi/RegeneronAdult patients with prurigo nodularisSeptember 2022
lumacaftor and ivacaftorOrkambi®vertexCystic fibrosis in patients 12 months to less than 24 months of age who are homozygous for the F508del mutation in the CFTR geneSeptember 2022
Risankizumab-rzaaSkyrizi®SOUTH CAROLINABoehringer Ingelheim/AbbVieCrohn's diseaseSeptember 2022
I believeStellar®Johnson & Johnson (Jansen)Pediatric patients 6 years and older with psoriatic arthritis (PsA)August 2022
belimumabBenlysta®GlaxoSmithKlinePatients 5 to 17 years of age with active lupus nephritisjulio 2022
ruxolitinib topical creamOpzelura®inciteNon-segmental vitiligo in adults and adolescents from 12 years of agejulio 2022
pegloticase + methotrexatechristmas®+ methotrexatehorizonteConcomitant use with methotrexate for the treatment of chronic goutjulio 2022
EstablecerMelanotidImcivree®rhythm pharmaceuticalsControl of obesity and hunger in adult and pediatric patients 6 years and older with Bardet-Biedl syndrome (BBS)June 2022
dupilumabduplicity®Sanofi/RegeneronFor adjuvant maintenance therapy in pediatric patients 6 months to 5 years of age with moderate to severe atopic dermatitisJune 2022
baricitinibOlumiant®Lilly/IncyteAlopecia areataJune 2022
mycophenolatmofetilCellcept®RocheOrgan Rejection Prophylaxis in Pediatric Heart and Liver Allograft RecipientsJune 2022
Brolucizumab-dblla Beov®Novartisdiabetic macular edemaJune 2022
RisdiplamEvrysdi®GenentechPresymptomatic infants under 2 months with Spinal Muscular Atrophy (SMA)mayo 2022
dupilumabduplicity®Sanofi PharmaFor the treatment of eosinophilic esophagitis (EoE) in adults and pediatric patients 12 years of age and older who weigh at least 40 kg (which is approximately 88 pounds).mayo 2022
baricitinibOlumiant®Lilly/IncyteFor the treatment of COVID-19 in hospitalized adult patients requiring supplemental oxygen, invasive or non-invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).mayo 2022
UpadacitinibRenew®AbbvieAdults with active ankylosing spondylitisApril 2022
Ravulizumab-cwvzUltomiris®AstraZeneca (Alexion)Generalized myasthenia gravis (gMG) that are anti-acetylcholine receptor antibody positiveApril 2022
remdesivirVeklury®GileadCertain pediatric patients 28 days of age and older who weigh at least 3 kilograms with positive direct test results for the SARS-CoV-2 virusApril 2022
Approvals of oncology products in the last 12 months
generic namebrand nameManufacturerIndicationsform of administrationApproval date
pirtobrutinibjaypirca®Lilly (Loxo)Certain forms of relapsed or refractory mantle cell lymphoma (MCL)OralJanuary 2023
rejoiceOrserdu®Radio Salud/ MenariniER+/HER2- advanced or metastatic breast cancerOralJanuary 2023
mosunetuzumab-axgblunsumio®GenentechCertain forms of relapsed or refractory follicular lymphomaIVDecember 2022
dose increaseKrazati®Targeted TherapeuticsSecond-line treatment of advanced non-small cell lung cancer (NSCLC)OralDecember 2022
OlutasidenibRezlidhea®Shape/RigelRelapsed or refractory acute myeloid leukemiaOralDecember 2022
docetaxeldocetaxel®(Meridian)Meridian-Laborscertain types of cancerIVNovember 2022
Tremelimumab-actlImjudo®AstraZeneca Med ImmuneCertain forms of non-small cell lung cancerIVNovember 2022
Mirvetuximab Soravtansin-GynxElahere®ImmunoGenCertain forms of ovarian cancer resistant to high platinum folate receptor alphaIVNovember 2022
keyboardamab-cqyvTecvayli®Johnson & Johnson (Jansen)Relapsed or refractory multiple myelomaIV o SCOctober 2022
Tremelimumab-actlImjudo®AstraZenecaCertain forms of inoperable hepatocellular carcinomaIVOctober 2022
FutibatinibLytgobi®Taiho-Onkologiemetastatic cholangiocarcinomaOralSeptember 2022
bortezomibbortezomib®HospiraMultiple myeloma

mantle cell lymphoma

IV o SCmayo 2022
AlpelisibVijoice®NovartisSevere Manifestations of the PIK3CA-Related Overgrowth Spectrum (PROS)OralApril 2022
(Video) 'Bloomberg Surveillance Simulcast' (03/01/2023)
New Indications for Approved Cancer Drugs
generic namebrand nameManufacturernew indicationApproval date
abemaciclibVersion®lilyCertain forms of hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2-)-negative early-stage breast cancer (EBC), with a high risk of recurrenceMarch 2023
I have delivered Limab-gxlyjelly®GlaxoSmithKline (Tesaro)/AnaptysBioRecurrent or advanced mismatch repair (dMMR)-deficient endometrial cancer, as determined by an FDA-approved test, that have progressed on or after platinum-based treatments and are not candidates for curative surgery or radiationFebruary 2023
sacituzumab govitecan-hziyTrodelvy®GileadPatients with HR+, HER2 breast cancer who received endocrine therapy and at least two other systemic therapies for metastatic cancer.February 2023
pembrolizumabkeytruda®BrandAdjuvant treatment of patients with stage IB, II, or IIIA non-small cell lung cancer (NSCLC) after complete surgical resectionJanuary 2023
tucatinibstuck®Seagen (formerly Seattle Genetics)HER2+ colorectal cancer who have received at least one prior treatment regimen for unresectable or metastatic diseaseJanuary 2023
ZanubrutinibHis brother®BeiGeneAdults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)January 2023
Rucaparib Camsylatblush®Clovis Oncologyperitoneal cancerDecember 2022
atezolizumabTecentriq®GenentechAlveolar soft tissue sarcomaDecember 2022
pemetrexedpemfexy®pharmaceutical eagleFirst-line treatment for non-small cell lung cancer other than squamous cell carcinomaDecember 2022
palbociclibIbrance®Pfizerhormone receptor positive breast cancerDecember 2022
Asparaginasa Erwinia chrysanthemi (recombinante) - RywnRylaze®Jazz-PharmaAcute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients 1 month of age and older who have developed hypersensitivity to E. coli-derived asparaginaseNovember 2022
Tremelimumab-actlImjudo®AstraZenecaMetastatic non-small cell lung cancer (NSCLC) without sensitizing EGFR mutation or anaplastic lymphoma kinase (ALK) genomic tumor alterations.November 2022
durvalumabSummary®AstraZenecaNSCLC without sensitizing EGFR mutation or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.November 2022
cemiplimab-rwlcYou are free®IVRegeneron/SanofiCertain forms of patients with advanced NSCLC without EGFR, ALK, or ROS1 aberrationsNovember 2022
Brentuximab betteryou will catch up®ViewPediatric patients with previously untreated high-risk classical Hodgkin lymphoma (cHL).November 2022
cemiplimab-rwlcYou are free®RegeneronNSCLC without EGFR, ALK, or ROS1 aberrationsNovember 2022
cobimetinibCotellic®Genentech (Roche)Adults with histiocytic neoplasmOctober 2022
selpercatinibRetevmo®Lilly (Loxo)Certain forms of locally advanced or metastatic solid tumors with rearrangement during transfection (RET)September 2022
durvalumabSummary®AstraZenecaUse in combination with standard chemotherapy to treat locally advanced or metastatic bile duct cancer (BTC)September 2022
pemigatinibPemazyre®inciteR/R myeloid/lymphoid neoplasms (MLN) with FGFR1 rearrangementAugust 2022
capmatinibTabrecta®NovartisCertain forms of metastatic NSCLCAugust 2022
For Darolutsyou skip®Bayer/OrionIn combination with docetaxel for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC)August 2022
fam-trastuzumab deruxtecan-nxkiget stronger®Daiichi Sankyo/AstraZenecaUnresectable or metastatic low HER2 breast cancerAugust 2022
crizotinibSolution®PfizerInflammatory myofibroblastic tumor (IMT)julio 2022
CarfilzomibKyprolis®Onyx (Amgen)R/R multiple myeloma (RRMM) who have received one to three lines of therapy.June 2022
Lisocabtagen MaraleucelBreyanzi®Bristol-Myers SquibbR/R large B-cell lymphoma (LBCL) after failure of first-line therapyJune 2022
dabrafenib and trametinibtafines®and machinist®NovartisAdult and pediatric patients 6 years of age and older with unresectable or metastatic BRAF V600E mutation-positive solid tumors that have progressed after prior treatmentJune 2022
fam-trastuzumab deruxtecan-nxkiget stronger®Daiichi Sankyo/AstraZenecaUnresectable or metastatic HER2-positive breast cancer that has previously received anti-HER2-based therapymayo 2022
tisagenlecleucelKymriah®NovartisFollicular lymphoma (FL) R/R after two previous lines of treatmentmayo 2022
nivolumab e ipilimumabopdivo®Yervoy®bristol myers squibbAdvanced, recurrent, or metastatic unresectable esophageal squamous cell carcinoma (ESCC)mayo 2022
ivosidenibTibsowo®Agios PharmaIn combination with azacitidine for newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation detected by an FDA-approved assay in adults 75 years of age or older or in patients with comorbidities that preclude the use of intensive induction chemotherapymayo 2022
azacitadineVidaza®Bristol Myers Squibb (Celgene)New indication of the inhibitor of nucleoside metabolism for the treatment of pediatric patients from one month of age with newly diagnosed juvenile myelomonocytic leukemia (JMML)mayo 2022
Axicabtagen CiloleucelYescarta®ContinueSecond-line treatment of adults with R/R large B-cell lymphomaApril 2022
special pipe
generic namebrand nameManufacturerIndicationsform of administrationExpected approval date*
toripalimabTuoyi™Junshi Biociencias/CoherusIn combination with gemcitabine and cisplatin for first-line treatment of patients with advanced metastatic or recurrent nasopharyngeal cancer/monotherapy for late or second-line treatment of patients with recurrent or metastatic NPC with disease progression during or after chemotherapy platinum basedIVLate
LenolisibN / AAgricultureActivated phosphoinositide 3-kinase delta syndromeOralMarch 2023
mirikizumabN / AlilyUlcerative colitisIV y SCApril 2023
tofersenN / ABiogenSuperoxiddismutase 1 (SOD1) Amyotrophic Lateralsklerose (SOD1-ALSintrathecalApril 2023
QuizartinibN / ADaiichi Sankyoacute myeloid leukemiaOralApril 2023
SER109 (Highly Purified Firmicutes Spore Consortium)N / ATherapeutic BeingsRecurrent C. difficile infectionOralApril 2023
palopegteriparatidoTransCon PTH™promotedhypoparathyroidismSOUTH CAROLINAApril 2023
pegunigalsidase alphaN / AChiesi/Protalix Global Rare DiseasesDevice DiseaseIVmayo 2023
[Vic-] Trastuzumab DuocarmazinaN / AByondisHER2 positive, unresectable, locally advanced or metastatic breast cancerIVmayo 2023
Nogapendequina alfa + BCGActive™immunityorganicbladder cancerIVmayo 2023
bimekizumabBimzelx™UCB PharmaceuticalsoriasisSOUTH CAROLINAmayo 2023
SomatrogonN / APfizer/Opko Pharmaceuticalsgrowth hormoneSOUTH CAROLINAmayo 2023
EpcoritamabN / AGenmab A/SR/R large B-cell lymphoma (LBCL) after two or more lines of systemic therapyIVmayo 2023
mometinibN / ASierra Oncology, Inc.mielofibrosisOralJune 2023
efgartigimodN / AArgenxgeneralized myasthenia gravis (gMG)SC- New formulationJune 2023
RitlecitinibN / APfizerAlopecia areataOralJune 2023
obeticholic acidN / Aintercept drugsnonalcoholic stratohepatitisOralJune 2023
glofitamabN / ARocheRelapsed or Refractory Large B-Cell LymphomaIVjulio 2023
NirsivamabBeyfortus™AstraZenecaPrävention des Respiratory Syncytial Virus (RSV)SOYjulio 2023
RozanolixizumabN / AUCBgeneralized myasthenia gravis (gMG)SOUTH CAROLINAjulio 2023
avacincaptad pegolZimura™organic chipboardGeographic Atrophy (GA) secondary to Age-Related Macular Degeneration (ARMD)intravitrealAugust 2023
elranatamabN / APfizerRelapsed or Refractory Multiple Myeloma (RRMM)SOUTH CAROLINAAugust 2023
NirogacestatN / ASpringWorks TherapyDesmoides-TumorenOralAugust 2023
Avasopasem-ManganN / ATherapeutic galleyOral mucositis (MOS) in patients with head and neck cancer (HNC) undergoing standard careIVAugust 2023
TalquetamabN / AJohnson & Johnson (Jansen)RRMMIVAugust 2023
Melphalan Chemo Saturation SystemHepzato-Kit™Sistema DelcathDrug/device combination for the treatment of inoperable dominant hepatic metastatic ocular melanoma (mOM)injectableAugust 2023
pozelimabN / ARegeneronCAPLE's diseaseIV o SCAugust 2023
zilucoplanN / AUCBgeneralized myasthenia gravisSOUTH CAROLINASeptember 2023
lebrikizumabN / Alilyatopic dermatitisSOUTH CAROLINASeptember 2023
I/Ontak (Denileukin Diftitox)N / Afaster drugsRecurrent Cutaneous T-Cell Lymphoma (CTCL)IVSeptember 2023
Motixafortida + G-CSFAphexda™ + G-CSFBioLineRx Ltd.Multiple myelomaSOUTH CAROLINASeptember 2023
etrasimodN / APfizerUlcerative colitisOralOctober 2023
CTP13 SC (remsima SC biomejor)N / ACelltrionCrohn's diseaseSOUTH CAROLINAOctober 2023
steam roleN / ASanthera Pharmaceuticals/ReveraGen BioPharmaDuchenne muscular dystrophy (DMD)OralOctober 2023
epontersenN / AIon-PharmaHereditary transthyretin-mediated amyloid polyneuropathy (ATTRv-PN)SOUTH CAROLINADecember 2023

* Estimated record dates are Prime Therapeutics predictions based on industry data.

(Video) Bond Market Bounce | Bloomberg Surveillance 02/27/2023

About Prime Therapeutics

Prime Therapeutics LLC (Prime) is a diversified pharmaceutical solutions organization serving health care plans, employers and government programs. Prime is jointly owned by 19 Blue Cross and Blue Shield plans, subsidiaries or affiliates of those plans. Magellan Rx Management, a Prime Therapeutics LLC company, is a pioneer in specialty and drug management and a leader in serving public sector government programs. Together, Prime and Magellan Rx offer a broad range of solutions for clients that bridge the gap between medical and pharmacy management. For more information visitwww.primetherapeutics.comYwww.magellanrx.com, or follow us on Twitter at @Prime_PBM and @Magellan_Rx.

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