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Mirum Pharmaceuticals and Incyte Announce U.S. FDA Approval of Atebrioz™ (zilurgisertib ...
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Fusion42 · 26 September 2026 · Fusion42 review
The U.S. FDA has approved Atebrioz™ (zilurgisertib), an oral ALK2 inhibitor, for treating adult and pediatric patients aged 12 and older with Fibrodysplasia Ossificans Progressiva (FOP). The drug will be available through Mirum Access Plus in the U.S. starting October, and the pediatric development program is ongoing for younger children.
This Wire brief sits within Fusion42's coverage of Drug Discovery, and 3 sources have reported it between 25 Sep 2026 and 4 Oct 2026.
◆ ◆ The Wire takeaway
Approval of this rare disease drug opens market access you can now target in paediatric and adult treatment of FOP. If you work on rare disease drug development or distribution, this authorises new opportunities in patient support and access programmes.
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3 sources · first reported 25 Sep 2026 · latest 4 Oct 2026
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