Drugs and FDA
FDA approves Mirum’s Atebrioz for FOP in patients aged 12 and older
Atebrioz is approved to reduce new bone formation outside the skeleton in adults and children aged 12 years and older with FOP.
The FDA approved Mirum Pharmaceuticals’ Atebrioz (zilurgisertib) tablets to reduce new bone formation outside the skeleton in adults and children aged 12 years and older with fibrodysplasia ossificans progressiva (FOP). The recommended starting dose is 100 mg by mouth once daily, with or without food, the FDA said.
In a trial, 63 patients received Atebrioz or placebo once daily for 24 weeks. At Week 24, the Atebrioz group had an average 3.2 cm³ decrease in new bone volume, while the placebo group had a 24.6 cm³ increase, according to the FDA. MedCity News reported that the trial missed statistical significance on its main measure, and that the FDA decision relied on secondary measures. Common side effects include headache, joint pain, upper respiratory tract infection, nosebleeds and nausea, the FDA said.
Reporting on this story
- MedCity News Mirum Pharma Pill Lands FDA Approval for Ultra-Rare Bone Growth Disorder (opens in a new tab)
- Healio FDA approves Atebrioz for fibrodysplasia ossificans progressiva (opens in a new tab)
- FDA Drugs FDA Approves Third Treatment for Fibrodysplasia Ossificans Progressiva (opens in a new tab)
