By Siddhi Mahatole Dec 12 (Reuters) – The U.S. Food and Drug Administration has approved an oral pellet formulation of BioCryst Pharmaceuticals’ drug to prevent attacks of severe swelling, or hereditary angioedema, in children aged two to under 12, the company said on Friday. The drug, Orladeyo, was already approved in late 2020 for hereditary […]
Health
FDA approves BioCryst’s oral pellet version of swelling disorder drug for children
Audio By Carbonatix
By Siddhi Mahatole
Dec 12 (Reuters) – The U.S. Food and Drug Administration has approved an oral pellet formulation of BioCryst Pharmaceuticals’ drug to prevent attacks of severe swelling, or hereditary angioedema, in children aged two to under 12, the company said on Friday.
The drug, Orladeyo, was already approved in late 2020 for hereditary angioedema as a once-daily capsule for those aged 12 and above.
The latest decision makes Orladeyo the first oral prophylactic therapy available for younger children with the 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 be poured directly into the mouth and swallowed with water or milk, making it easier for young children who cannot swallow capsules.
“We expect that Orladeyo oral pellets will be available in April 2026,” said a BioCryst spokesperson in an email to Reuters.
The company said it intends to maintain pricing parity across all available doses.
BioCryst had set a wholesale acquisition cost for the capsule version of Orladeyo at $485,004 on an annual basis in the U.S., or $37,308 per 28-day pack of either 150mg/110mg capsules, according to filings as of December 2020.
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)