Reata Granted Pre-NDA Meeting for Omaveloxolone
Reata Pharmaceuticals has been granted a preliminary meeting with the U.S. Food and Drug Administration (FDA) to discuss the submission of a new drug application (NDA) for omaveloxolone, an investigational treatment for Friedreich’s ataxia (FA).
According to a company press release, the pre-NDA meeting is scheduled to take place during the third quarter of this year and briefing materials for review have been submitted. Reata expects to submit the NDA for omaveloxolone at the beginning of 2022.
Studies have shown that Reata’s clinical candidate omaveloxolone restores mitochondrial function, which is impaired in people with FA, and also reduces oxidative stress (an imbalance in the production of harmful molecules that can lead to cell damage and death). It does so by targeting a protein that controls the activity of several genes called nuclear factor erythroid 2-related factor 2 (Nrf2).
According to data obtained in the MOXIe Phase 2 (NCT02255435) trial, a two-part, randomized and placebo-controlled clinical study, omaveloxolone significantly improved neurological function, after nearly one year of use, in people with FA, and was found to be generally safe and well tolerated.
Based on the findings, more than 74,000 people worldwide, including family members, friends, and FA experts, signed a petition from the Friedreich’s Ataxia Research Alliance (FARA) requesting Reata to submit an NDA for omaveloxolone and for the FDA to approve its use as a treatment for FA.
FA currently has no approved treatments, so omaveloxolone’s benefits, in terms of neurological function and activities of daily living, as well as its positive safety profile, are considered by FARA as worthy to receive FDA approval.
Reata originally was meant to hold a Type C meeting with the FDA, which was unrelated to the NDA requests. But review of the Type C meeting briefing material led the FDA to suggest that a pre-NDA meeting was more suitable.
The company also announced it has presented results from its FA program at the National Ataxia Foundation’s Ataxia Investigators Meeting, held virtually in May. The talk was titled “Efficacy of Omaveloxolone in Patients with Friedreich’s Ataxia: Baseline-Controlled Study.”
Overall, the data presented provided additional evidence of efficacy for omaveloxolone in FA, as the majority of patients were stable or saw their condition improve during treatment with the therapy.