Biogen's Reata Pharmaceuticals acquisition brings Skyclarys, the first and only FDA-approved therapy for the rare neuromuscular disease Friedreich’s ataxia. Biogen says Skyclarys complements the other neuromuscular drugs in its portfolio.
Skyclarys, a Reata Pharmaceuticals drug, is now approved for treating the rare neuromuscular disorder Friedreich’s ataxia. The decision makes the capsule the first therapy for a disease that’s rarer than either Duchenne muscular dystrophy or spinal muscular atrophy.
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The FDA approved drugs from Johnson & Johnson and CTI BioPharma in the past week. Complete response letters were issued to Gilead Sciences, Amryt, and Reata Pharmaceuticals.
The FDA told Reata that the clinical data do not show that the drug, bardoxolone, slows the progression of the loss of kidney function in patients who have the rare disease Alport syndrome. The regulatory decision follows an FDA advisory committee vote recommending against approval of the small molecule drug.
Shares of Texas-based Reata rose 60 percent Tuesday following the announcement of results from its registration-directed Phase II study of omaveloxolone. The company reacquired rights to that and other drugs from AbbVie last week. FA has no approved treatments.