US FDA approval tracker: December 2019

The FDA’s run of speedy approvals continued in the last month of 2019. Two antibody-drug conjugates, Seattle’s Padcev and Astra/Daiichi’s Enhertu, came early, alongside Newlink/Merck’s Ebola vaccine Ervebo. Approval of Sarepta’s second Duchenne’s therapy, Vyondys 53, came out of the blue mid-month, reversing a previous complete response letter, while Intracellular’s shares rocketed 193% after its schizophrenia treatment Caplyta got the green light despite mixed clinical data. Amarin's Vascepa gained a broad cardiovascular label including a primary prevention setting; however, risk from litigation and upcoming competition overhangs this drug. Allergan’s Ubrelvy became the first oral CGRP antagonist for acute migraine, but Biohaven’s competing offering has its own PDUFA date set for early 2020. Meanwhile, Enzyvant’s RVT-802, a regenerative tissue therapy in development for congenital athymia, was knocked back owing to manufacturing concerns – not a great start to the $3bn strategic alliance Sumitomo Dainippon signed with Roivant, Enzyvant’s holding company, back in September.