US FDA approval tracker: February 2023

There were several high-profile approvals last month, including for Apellis’s Syfovre, given a broad label and a flexible dosing regimen in geographic atrophy. However, Apellis might not have the market to itself for long as Iveric Bio’s Zimura has a Pdufa date in August. Reata gained a surprise greenlight for its Friedreich's ataxia therapy Skyclarys, despite a complex regulatory path. However, Cytokinetics received a knockback for its heart failure project omecamtiv after an earlier negative adcom. The company has no plans to run another study, leaving it to focus on aficamten in obstructive hypertrophic cardiomyopathy, with phase 3 data due later this year. Lastly, the outcome of an adcom for Pfizer’s adult respiratory syncytial virus (RSV) vaccine Abrysvo was less clear-cut than might have been expected, with a 7 to 4 vote in favour. Panellists highlighted incidences of Guillain-Barré Syndrome, and post-marketing studies are expected to evaluate this risk. Stifel analysts note that GSK, whose own vaccine Arexvy is up before a panel today, has agreed with the FDA to monitor the syndrome as part of its pharmacovigilance programme.