FDA approves Lundbeck's Onfi for rare, severe epileptic seizures
This article was originally published in Scrip
Lundbeck and its US manufacturing partner Catalent Pharma won US FDA approval of Onfi (clobazam) as an adjunctive treatment for seizures in patients two years and up with Lennox-Gastaut syndrome, a rare but severe form of epilepsy.
You may also be interested in...
Biocodex's Diacomit – long approved in the EU – just won FDA approval. That brings the number of drugs cleared for Dravet in the US to two, including GW Pharma's recently endorsed Epidiolex, and the R&D pipeline for this rare seizure disorder is growing.
With new funding in hand, Moderna and its infectious disease venture Valera are going full-speed ahead with a Zika vaccine, taking an mRNA approach, which they said could be a more rapid strategy to try to stop the disease.
Allergan CEO Brent Saunders vows not to engage in price gouging and says his firm will limit cost increases to single-digit percentages, occurring only once per year. But it's unclear whether Saunders will stand as a lone wolf in the industry or if others will make similar pledges.