US FDA approval tracker: February

Snippets

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.

Notable first-time US approval decisions in February
Project Company 2024e sales ($m) Outcome
Nexletol and Nexlizet (bempedoic acid/+ ezetimibe) Esperion 958 Both approved
Nurtec ODT (rimegepant/Zydis ODT) Biohaven 868 (rimegepant franchise) Approved
Ayvakit Blueprint Medicines 725 Delayed until May 14 (fourth-line GIST)
Vyepti (eptinezumab) Lundbeck/Teva 404 Approved
Twirla Agile Therapeutics 216 Approved
Posimir Durect 134 No decision yet
Barhemsys Acacia Pharma 103 Approved
Pizensy Braintree labs - Approved
Anjeso (Intravenous meloxicam) Baudax Bio - Approved
Taclantis Sun Pharma Advanced Research - CRL
Sources: EvaluatePharma, Go or no go? Esperion's double whammy and a look to priority reviews.

 

Supplementary and other notable approval decisions in February
Product Company Event type Outcome
Keytruda Merck sBLA to include every-six-weeks dosing for melanoma and multiple other indications CRL
Vesicare Astellas sNDA for neurogenic detrusor overactivity in paediatric patients No decision yet
Neratinib Puma Biotechnology sNDA in combination with capecitabine in advanced Her2-positive breast cancer Approved
Sources: EvaluatePharma, Go or no go? Esperion's double whammy and a look to priority reviews.

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