Regeneron to challenge Ipsen as FDA clears bone disease drug
Pasatru’s approval sets up a market battle in a rare indication where the only available treatment has generated disappointing sales.
The US FDA has approved Regeneron's treatment for fibrodysplasia ossificans progressiva (FOP), a rare disease that causes muscle and connective tissue to be replaced with bone. The approved treatment is called garetosmab, also referred to as Pasatru by STAT News.
According to STAT News, people with FOP typically rely on wheelchairs by age 25 as bone accumulation locks up their limbs, and only some live into their 50s. The hope is that garetosmab can help patients maintain their mobility and live longer.
The approval was based on a pivotal trial led by Richard Keen of London’s Royal National Orthopaedic Hospital. Keen stated that the treatment "almost completely stops the new [bone] forming, and therefore their condition will not deteriorate."
Brief written by urgent.news from Endpoints News, STAT News — 2 reports on this story. Machine-written — may contain errors; check the original before relying on it.
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