US FDA approval tracker: March

Snippets

Bristol-Myers Squibb’s Zeposia was given the green light in multiple sclerosis last month, but the news was marred by the Covid-19 pandemic, with the company saying it was holding off launching for now. On the plus side Zeposia’s label does not require cardiac monitoring during treatment initiation like Novartis’s rival S1P modulator, Gilenya. Meanwhile, the decision for Zogenix’s Fintepla in Dravet syndrome, a rare form of childhood epilepsy, was delayed until June, leaving the market to GW's Epidiolex for a while longer. Sanofi’s multiple myeloma treatment Sarclisa gained approval as a third-line treatment in combination with Pomalyst plus dexamethasone. Additional trials are under way to expand the settings, and this quarter should see data from the Ikema study in second-line use, but Genmab’s rival anti-CD38 MAb Darzalex is a force to be reckoned with. Those that received negative decisions included Intelgenx, which suffered its fourth knockback, and Intarcia its second.

Notable first-time US approval decisions in March
Project Company 2024e sales ($m) Outcomes
Zeposia (ozanimod) Bristol-Myers Squibb 966 Approved
Fintepla Zogenix 685 Extended to June 25
Sarclisa (isatuximab) Sanofi 516 Approved early (1 month)
Durysta (bimatoprost SR/implant) Allergan 124 Approved
Isturisa (osilodrostat) Recordati 40 Approved
Travivo Fabre-Kramer Pharmaceuticals - No decision yet
Rizaport/RNG-103 Intelgenx Technologies - CRL
ITCA 650 Intarcia - CRL
ET-105 Aucta/Eton - CRL
E-58425 Esteve - No decision yet
Sources: EvaluatePharma, Go or no go? Ozanimod and Fintepla await FDA verdicts. 

 

Supplementary and other notable approval decisions in March  
Product Company Event type Outcome
Opdivo+Yervoy Bristol-Myers Squibb/Ono sBLA for previously treated patients with hepatocellular cancer, based on Checkmate-040 study Approved
IV Triferic Rockwell sNDA for anaemia in chronic kidney disease Approved
Imfinzi Astrazeneca sBLA for first-line SCLC, based on Caspian trial Approved
Jardiance Boehringer Ingelheim/Lilly sNDA as an adjunct to insulin for adults with type 1 diabetes CRL
Epclusa Gilead sNDA children aged 6 and older with chronic Hep C Approved
Sources: EvaluatePharma, Go or no go? Ozanimod and Fintepla await FDA verdicts. 

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