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FDA Approves Mirum’s Atebrioz for FOP Patients

By Drooid · · How we work

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Story summary
  • The U.S. FDA approved Mirum Pharmaceuticals’ oral drug Atebrioz for fibrodysplasia ossificans progressiva.
  • Atebrioz (zilurgisertib) is approved for patients aged 12 years and older.
  • The 63-patient PROGRESS trial showed a 3.2 cm³ reduction in new bone versus 24.6 cm³ with placebo.
  • Atebrioz cut new-lesion incidence to 3.1% compared with 16.7% on placebo.
  • Analysts project an annual price of about $750,000 and peak worldwide sales near $150 million.