BioCryst Pharmaceuticals (BCRX) supplemental new drug application for the oral pellet formulation of once-daily Orladeyo as a prophylactic therapy for hereditary angioedema has been approved by the US Food and Drug Administration, the company said Wednesday.
The 150 milligram pellet formulation which can be poured directly into the month is meant for adults and adolescents aged 12 or older, the company said.
In two clinical studies, the capsules reduced sustained attacks in patients by 91% at 96 weeks, the company said.
Shares of the company were up 1.8% in recent premarket trading.
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