Mirum and Incyte win FDA approval for Atebrioz in rare bone disease
Mirum says the drug could bring in more than $200 million a year, and separately reports strong Phase 3 results for a hepatitis delta treatment
Published
The Food and Drug Administration has approved Atebrioz, developed by Mirum Pharmaceuticals and Incyte, to reduce new bone growth in patients aged 12 and older with fibrodysplasia ossificans progressiva, a rare disorder in which soft tissue turns to bone. The companies expect it to reach pharmacies in the United States in October. Mirum estimates the drug's total annual revenue potential at more than $200 million.
Mirum also announced results from its Phase 3 AZURE-1 study of brelovitug in chronic hepatitis delta. The trial met its main goal at week 24: 56% of patients on the 300 mg weekly dose and 45% on the 900 mg dose given every four weeks reached the combined target of viral suppression and normalized liver enzymes, compared with none of the patients whose treatment was delayed. Mirum now puts brelovitug's annual revenue potential in hepatitis delta at more than $1 billion.
The two announcements give Mirum a rare pairing: a newly approved rare-disease drug already headed to market, and a late-stage candidate aimed at a disease with few treatment options and a poor prognosis. That combination sets the company apart from a run of recent drug approvals that have mostly offered incremental gains in already crowded treatment categories, and it is what makes the billion-dollar estimate for brelovitug look grounded rather than promotional.