![]() This situation with omaveloxolone is not the first time Reata and the FDA have crossed swords. Reata stressed it’s still waiting to receive formal minutes from its mid-cycle review meeting with regulators. The FDA is expected to make its decision by Nov. ![]() We have submitted these additional data and analyses to the FDA and are continuing to prepare for the upcoming Advisory Committee meeting,” said Warren Huff, Reata’s CEO. “We look forward to continuing to work with FDA on its review of our NDA for omaveloxolone for the treatment of patients with Friedreich’s ataxia, a rare, genetic, debilitating, and degenerative neuromuscular disorder with no approved therapies. The company said that the new data points got the all-clear and could move forward in the NDA process. Reata also gave the regulator a new analysis and new evidence in the setting of the disease’s pathophysiology. The company updated its results, which now contain both new and later time points in the trial, as well as bumped up the numbers of patients. Reata reported that it went to several lengths to dampen the FDA’s misgivings. They have not identified any other major safety concerns at this stage of their review,” the Q2 report said. ![]() The FDA stated that the safety review is ongoing, and they are continuing to evaluate the cardiac safety of omaveloxolone in patients with Friedreich’s ataxia. The FDA did not identify any significant clinical safety issues. “ continues to have concerns regarding the strength of the efficacy evidence. According to the company’s Q2 report, the FDA might still not be sold on the drug. Reata Pharmaceuticals is facing an FDA wall on its small molecule candidate to treat Friedreich’s ataxia, omaveloxolone.
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