Plano-based Reata Pharmaceuticals has cleared the final FDA hurdle to get its rare-disease drug Skylarys on the market, the company announced Tuesday. The drug is now available to U.S. patients who’ve been diagnosed with Friedreich’s ataxia—a genetic disorder that can cause progressive damage to the nervous system, resulting in difficulties in walking and speech and movement problems.

Skylarys is the first and only FDA-approved drug for the treatment of Friedreich’s ataxia in adults and adolescents aged 16 years and older, the company said.

“As a company, this is a transformative milestone that highlights our commitment to developing and commercializing novel therapies for patients with severe diseases with few or no approved therapies,” Warren Huff—Reata’s founder, president, chairman, and CEO—said in a statement in March, when his company received initial U.S. Food and Drug Administration approval for Skylarys and saw its stock soar. 

You can read more about the drug—and the condition it treats—in our March story.

Reata’s first drug approval since its 2002 founding

The announcement marks Reata’s first drug approval since the company was founded in 2002, according to the Dallas Morning News, which noted that the approval came just one month after Reata shut down its decade-long work on a chronic kidney disease drug due to the lack of significant long-term effectiveness shown during patient trials.

Skylarys’ many years of development are reflected in its cost. Reata is set to price the drug at $370,000 for a year’s worth of once-daily medication, the DMN’s Megan Farrer reported.

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