Mirum Pharma's Atebrioz Gets USFDA Nod for Rare Bone Disorder FOP
Bengaluru: The US Food and Drug Administration has approved Mirum Pharmaceuticals' drug to treat a rare bone disorder, the regulator said on Friday.
The drug, zilurgisertib, branded as Atebrioz, is a once-daily oral treatment for patients aged 12 years and older with fibrodysplasia ossificans progressiva (FOP), a genetic disorder that causes bone to form in muscles, tendons and ligaments, restricting movement and leading to severe disability.
Atebrioz blocks ALK2, a protein that is abnormally active in most patients with FOP and drives bone formation outside the skeleton. The recommended dose is 100 milligrams.
Mirum expects to launch the drug in October and plans to announce its price at launch, Mirum CEO Chris Peetz told Reuters.
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