Incyte, Mirum's Treatment of Rare Genetic Ossification Condition Approved by US FDA

MT Newswires Live09-28 16:25

Incyte (INCY) and Mirum Pharmaceuticals' (MIRM) Atebrioz tablet has been approved by the US Food and Drug Administration to treat adult and pediatric patients aged 12 years and older with fibrodysplasia ossificans progressiva, the companies said Friday.

The disease is a very rare genetic disease in which bone forms in muscles, tendons, ligaments and other soft tissues, progressively restricting movements. The drug reduces the volume of new ossification, they said.

The drug, developed by Incyte and licensed to Mirum Pharmaceuticals, is expected to be available in the US in November, the companies said.

The FDA also granted Incyte a rare pediatric disease priority review voucher which can be used in a later application, the companies said.

The European Union is also now reviewing a marketing authorization application for the drug, the companies said.

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