Reata Pharmaceuticals have announced that the US Food and Drug Administration (FDA) has granted Fast Track Designation for omaveloxolone for the treatment of Friedreich’s ataxia. This will enable Reata to have more frequent communication with the FDA and if relevant criteria are met, they will be eligible for FDA programs such as priority review. Reata plan to submit a New Drug Application to the FDA for approval of omaveloxolone during the first quarter of 2022.
Read the press release here.
In a recent update on their clinical programmes, Reata Pharmaceuticals announced that they have scheduled a pre-New Drug Application (pre-NDA) meeting with the US Food and Drug administration (FDA) during the third quarter of this year. This is typically the last formal interaction with the FDA prior to a New Drug Application (NDA). They plan to submit the NDA for omaveloxolone to the FDA during the first quarter of 2022.
Euro-ataxia Conference 2021: Reata update on omaveloxolone study in FA
Ataxia UK was delighted to have Dr Colleen Stoyas, who is a Medical Science Liaison at Reata Pharmaceuticals, present an update on the MOXIe study which evaluates the safety and efficacy of omaveloxolone (Omav) in Friedreich’s ataxia (FA) at the Euro-ataxia conference 2021 on Friday 18th June 2021.
Dr Stoyas began with an overview of the mechanism of Omav in FA. She then explained that to test Omav in FA, Reata used mFARS (Modified Friedrich’s Ataxia Rating Scale), which is a physician-assessed neurological exam that tracks progression of FA. This was followed with a summary, key findings, and safety summary of the last 6 years, where Reata has been sponsoring the MOXIe study which consists of 3 parts: MOXIe Part 1, MOXIe Part 2, and the Open-Label Extension.
An important finding shared was data from the MOXIe extension study was also analysed in the Delayed-Start Analyses. The results of this study indicate that the slowing of progression measured by mFARS is due to Omav treatment and Reata feel are indicative of Omav modifying the progression of FA.
During the Q and A session, a question was asked that if Omav was approved in the UK, whether it would be available for children? Dr Stoyas replied that currently the youngest age in the MOXIe inclusion criteria was 16 years old, and therefore, a pediatric safety study will likely be required.
Please find the presentation slides here.
Reata Pharmaceuticals is investigating the benefits of a new drug called omaveloxolone – a potential therapy for Friedreich’s ataxia (FA). In order for omaveloxolone to be passed for use in the USA it must be approved by their Food and Drug Administration (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: