Rockville’s ReveraGen BioPharma Inc., a 15-year-old Children’s National Hospital spinout, is preparing for the launch of its neuromuscular disease drug — and sees an opportunity to advance it for other conditions.
ReveraGen scored the Food and Drug Administration’s approval in late October for its treatment for Duchenne muscular dystrophy, or DMD, the most common and severe type of muscular dystrophy that plagues young boys with progressive muscle weakness and atrophy.
The therapy, called vamorolone, has anti-inflammatory properties similar to traditional corticosteroids such as prednisone — but without typical complications such as weakened bones and stunted growth.
For decades, the market has lacked a steroid “that’s able to keep the benefit, but mitigate some of the side effects,” said Eric Hoffman, president and CEO of ReveraGen.
The drug showed in clinical trials to improve muscle strength and stature in DMD patients, and otherwise was comparable in its effects to corticosteroids, the standard of care for DMD. It’ll be sold starting in 2024 under the brand name Agamree by Coral Gables, Florida-based Catalyst Pharma Inc., via a sublicensing deal with Switzerland’s Santhera Pharmaceuticals.
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