FDA approves Reata’s rare nervous-system drug amid questions about changing regulatory environment for neuroscience treatments
The U.S. Food and Drug Administration on Tuesday approved Reata Pharmaceuticals Inc.’s treatment for Friedreich’s ataxia, a rare inherited disease that causes damage to the nervous system.The drug, omaveloxolone, which is now called Skyclarys,... The U.S. Food and Drug Administration on Tuesday approved Reata Pharmaceuticals Inc.’s treatment for Friedreich’s ataxia, a rare inherited disease that causes damage to the nervous system.
The approval comes one day after the departure of Billy Dunn, the FDA’s head of neuroscience. The announcement, which was confirmed by the FDA, moved the stocks of several companies with neurology drugs under review at the FDA on Monday. It also caught the attention of Wall Street analysts, who largely view Dunn’s exit from the FDA as a loss for the industry.
A congressional report released in December that assessed Aduhelm’s approval process said Dunn met with Alfred Sandrock, then the head of Biogen’s research and development, to discuss the failed clinical trials for Aduhelm. “Documents obtained from FDA show that following the meeting in Philadelphia, Biogen re-engaged in conversations with the agency,” the report stated.
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