Reata Pharmaceuticals is investigating the benefits of a new drug called omaveloxolone – a potential therapy for Friedreich’s ataxia (FA). In order for omaveloxone to be passed for use in the USA it must be approved by their Food and Drug Adminstration (FDA). Approval in the USA may hasten approval in other countries.
Reata Pharmaceuticals have announced that they received a communication from the FDA (United States Food and Drug Administration) stating that, after a preliminary review of briefing materials for an upcoming Type C meeting, a pre-New Drug Application (pre-NDA) meeting is the most appropriate format for a discussion of the development program for omaveloxolone in Friedreich’s ataxia.
Reata now plan to withdraw the current request for a Type C meeting and submit a request for a pre-NDA meeting. A Type C meeting is a general meeting regarding the development and review of a drug, while a pre-NDA is a specific meeting to discuss the content of a New Drug Application. It is typically the last formal interaction with the Food and Drug Administration prior to a New Drug Application (NDA). Therefore, this represents a positive step forward for the potential approval of omaveloxolone by the FDA. Find the press release here.
The news follows the Friedreich’s Ataxia Research Alliance’s (FARA) recent petition, supported by Ataxia UK, which was signed by over 74,000 people, asking Reata to submit an NDA for omaveloxolone and the FDA to consider its approval based on existing evidence.
Ataxia UK regards this as positive news. Keep a look out on our website and social media channels for updates regarding Omaveloxolone.
Date posted: 17/05/2021
Reata Pharmaceuticals is a clinical-stage biopharmaceutical company, and one of their most advanced clinical candidates is omaveloxolone, which is being investigated in clinical trials as a potential treatment for Friedreich’s ataxia (FA). To find out more about omaveloxolone, click here.
In the latest press release they reported that new data from ‘Delayed-Start Analyses’ suggest disease-modifying activity with omaveloxolone. They claim this provides evidence supporting the positive primary endpoint findings in MOXIE Part 2, and provides additional evidence of the effectiveness of omaveloxolone in patients with FA.
Reata requested and were granted a Type C meeting with the FDA (United States Food and Drug Administration) to discuss their data analyses, and overall FA development program. The meeting will occur later this year.
Also, later this year, Reata is planning to initiate a second pivotal study, which will incorporate input from the FDA and European Medicines Agency into the protocol, before enrollment begins.
Ataxia UK’s research team have reported on omaveloxolone previously. Please find below links to our previous articles on this topic: