Reata Pharmaceuticals has done its homework in responding to the FDA’s concerns about an application for its nerve disorder drug. But now the biotech has to sit tight for an extra three months while the agency mulls things over.
The FDA had previously raised concerns in a meeting with Reata about the company’s application to approve a drug called omaveloxolone for the inherited nerve disorder Friedreich's ataxia. As a result, the company submitted an updated analysis of its MOXIe extension study for the drug using data up to March, as well as an analysis of the relevance of Nrf2—a transcription factor that is the target of omaveloxolone—to the pathophysiology of Friedreich’s ataxia.
The agency told Reata yesterday that these submissions comprised a major amendment to the application and pushed back its decision date by three months to Feb 28, 2023.
The drug has had a lively journey towards potential approval, including surprising analysts by meeting its primary endpoint in a phase 2 trial back in 2019. The company is betting that Nrf2—which induces molecular pathways that promote the resolution of inflammation by restoring mitochondrial function, reducing oxidative stress and inhibiting pro-inflammatory signaling—will hold the key to providing the first treatment for Friedreich's ataxia.
“We are pleased with the FDA’s decision to review the new information we recently provided to the division,” said Reata CEO Warren Huff. “We remain committed to our goal of working with the FDA to secure regulatory approval for omaveloxolone as quickly as possible for patients with this severe disease that has no approved therapies.”
Reata’s other most advanced clinical candidate, bardoxolone, has had its own problems with the FDA. Last December, a panel of advisers voted unanimously that the chronic kidney disease med, which also targets Nrf2, was not effective. This was followed up by a complete response letter from the FDA in February confirming the drug’s application could not be approved in its current form.