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FDA approves Mirum, Incyte's Atebrioz for fibrodysplasia ossificans progressiva patients 12 and older

25. Sep 2026

(AWP Alliance News) - The U.S. FDA cleared Mirum Pharmaceuticals' Atebrioz (zilurgisertib), an ALK2 inhibitor from Incyte, for adults and patients aged 12 and older with fibrodysplasia ossificans progressiva. The drug is indicated to reduce the volume of total new heterotopic ossification.

Mirum expects a U.S. launch in October. The FDA also issued a Rare Pediatric Disease Priority Review Voucher to Incyte.

https://www.businesswire.com/news/home/20260925436454/en/

Disclaimer: This news brief was created using generative artificial intelligence. Incyte Corporation published the original content used to generate this news brief via Business Wire on September 25, 2026, and is solely responsible for the information contained therein.

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