US FDA approval tracker: February 2020

The already crowded migraine space saw two more approvals last month: Lundbeck/Teva’s intravenous anti-CGRP MAb Vyepti got the green light in the preventative setting while Biohaven’s Nurtec ODT, a fast-acting formulation of the oral CGRP rimegepant, was approved as an acute treatment. Importantly for Biohaven, data in prevention are due before the end of March and could position rimegepant as a more convenient alternative to approved injectable CGRP inhibitors. Esperion received two approvals for its cholesterol-lowering project bempedoic acid, one as a monotherapy and the second in combination with ezetimibe. Being oral, the drug is more convenient than injected PCSK9s, but Esperion will have to wait a couple more years until the Clear Outcomes trial reports to see if it can claim any cardiovascular benefits. Finally, after six previous rejections between them, Twirla, Anjeso and Barhemsys all got approved.