Dec 12 (Reuters) – The U.S. Food and Drug Administration has approved an oral pellet formulation of BioCryst Pharmaceuticals’ drug to prevent hereditary angioedema attacks in children aged 2 to under 12, the company said on Friday.
Shares of Research Triangle Park, North Carolina-based drugmaker were up 5% in premarket trading.
The drug, Orladeyo, was already approved as a once-daily capsule for patients aged 12 and older in December 2020.
With the FDA’s latest decision, the drug becomes the first oral prophylactic therapy available for younger children with hereditary angioedema, a rare genetic disorder that can cause sudden and sometimes life-threatening swelling in the face, throat and other parts of the body.
The oral pellet formulation which has a sprinkle-like appearance can be mixed with soft food or can be poured directly into the mouth and swallowed with water or milk, making it easier for young children who cannot swallow capsules.
Until now, children under 12 could only get targeted treatments through intravenous infusions or under-the-skin injections, which can be difficult for young patients and their caregivers, the company said.
BioCryst has also sought marketing approval in Europe and Japan for the use of the Orladeyo oral pellets in children aged 2 to 12.
In October, BioCryst said it would buy Astria Therapeutics in a deal valued at about $700 million, to get access to navenibart, being developed as a long-acting injectable therapy for hereditary angioedema.
(Reporting by Siddhi Mahatole in Bengaluru; Editing by Shailesh Kuber)
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