Reata continues to hit FDA roadblocks with its Friedreich’s ataxia candidate, noting regulator 'concerns'
Reata Pharmaceuticals is facing an FDA wall on its small molecule candidate to treat Friedreich’s ataxia, omaveloxolone. According to the company’s Q2 report, the FDA might still not be sold on the drug.
“[The FDA] continues to have concerns regarding the strength of the efficacy evidence. The FDA did not identify any significant clinical safety issues. 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. They have not identified any other major safety concerns at this stage of their review,” the Q2 report said.
Reata reported that it went to several lengths to dampen the FDA’s misgivings. 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 also gave the regulator a new analysis and new evidence in the setting of the disease’s pathophysiology. The company said that the new data points got the all-clear and could move forward in the NDA process.
“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. 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.
The FDA is expected to make its decision by Nov. 30. Reata stressed it’s still waiting to receive formal minutes from its mid-cycle review meeting with regulators.
This situation with omaveloxolone is not the first time Reata and the FDA have crossed swords. In 2021, the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 13-0 that the agency should not approve its bardoxolone methyl capsules as a treatment to slow the progression of chronic kidney disease in those with Alport syndrome after panelists felt that the drug had no effect in treating the disease.
Investors were initially bullish on the drug as it showed positive data in 2019. However, in 2020, the FDA delayed omaveloxolone’s NDA pending completion of a second trial, delaying progress and causing its stock price to drop.
The latest news is still not what investors want to hear as the company has been facing a 70% drop in its price $RETA since August of last year. And in early Monday trading, Reata shares were down more than 30%.