ARTICLE | Regulation
Boxed warning on Zogenix’s Dravet syndrome therapy could hamper market prospects
Agency rebuffs wet AMD therapy from AbbVie, Molecular Partners, approves Chiasma’s oral acromegaly drug
June 27, 2020 1:57 AM UTC
FDA’s approval of a resubmitted NDA for Fintepla to treat seizures associated with Dravet syndrome sets Zogenix up to compete with GW’s Epidiolex in the rare epilepsy market, but the drug’s prospects may be hampered by a boxed warning on its label for valvular heart disease and pulmonary arterial hypertension.
The decision came late Thursday, a day before FDA issued decisions on therapies from AbbVie Inc. (NYSE:ABBV) and Chiasma Inc. (NASDAQ:CHMA). ...