
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.
Notable first-time US approval decisions in February | |||
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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. |