US FDA approval tracker: March 2020

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.