Reata’s ‘regulatory concerns’ turn into three-month delay on FDA decision for Friedreich’s ataxia drug
In its Q2 report Monday, Reata Pharmaceuticals said that the FDA continues to have concerns about its Friedreich’s ataxia drug.
On Tuesday, those concerns manifested in a three-month delay on an FDA approval decision. Reata’s new FDA decision deadline for its Friedreich’s ataxia drug, omaveloxolone, is the end of February 2023, it announced this morning.
In the Q2 report, Reata noted that the FDA was concerned about the efficacy of omaveloxolone. The Plano, TX-based biotech said that in response to those concerns, it submitted additional data from its clinical trial. But in order to review that new data, the FDA needs more time, hence the three-month delay, Reata said Tuesday morning.
Friedreich’s ataxia is a rare genetic disease in which nerve fibers degenerate over time. In 2019, Reata surprised analysts with a positive readout on its pivotal omaveloxolone trial. However, that initial buzz died a year later when the FDA said the supplemental data Reata submitted on its pivotal trial was not enough, requesting that the biotech run an additional trial.
Reata’s stock $RETA dropped around 30% Monday morning in reaction to the news of another delay on the drug.
While there is currently no approved treatment for Friedreich’s ataxia, the few biotechs that have gone after the indication haven’t seen much success. In 2016, Horizon’s $50k/month drug Actimmune, already approved for two other indications, flunked a Phase III trial for Friedreich’s ataxia. And Larimar Therapeutics’ Phase I program has been on clinical hold after non-human primates died in preclinical testing.
On other dates with the FDA, Reata hasn’t fared well either. Last year, an FDA adcomm voted unanimously against Reata’s potential Alport syndrome treatment.