We Need Your Help
Hey, how are ya?!
When I say “we,” I am referring to every member of Friedreich’s ataxia (FA) Community. Such as individuals affiliated with FA, families, friends, caregivers, supporters, and other rare disease advocates.
As you may know, there is not a cure or treatment available to treat this degenerative life-threatening disease. However, after many years of tireless research and clinical trials, an amazing pharmaceutical company, Reata Pharmaceuticals, discovered a possible treatment for FA.
The treatment, Omaveloxolone (Omav), has shown promising results, based on the clinical trials performed on FA patients. Many patients have seen a large improvement in ease of performing day to day activities compared to not taking the treatment. However, the Food and Drug Administration (FDA) has not approved Omav to become available for use. The FDA did not believe that the clinical trial results captured enough data for expedited approval and are pushing Reata to conduct another trial before considering commercialization.
The FDA asked Reata for more evidence, and Reata proposed a crossover design to produce more data without having to host another clinical trial. However, the FDA didn’t think the crossover design was sufficient and are still pushing for further testing.
Now, the Friedreich’s Ataxia Research Alliance & Reata are preparing a letter to send that’ll go along with a second New Drug Application (NDA) to the FDA requesting that Reata submit an NDA on an urgent basis and FDA to consider approval of an NDA for Omav.
Every signature on the letter may allow individuals with Friedreich Ataxia Access to Omav. As of Tuesday, the letter has over 38,000 signatures! The signature period will be open until January 20th. On behalf of the FA Community, I ask that YOU please sign the letter.
Together We Will Cure FA!
One Love, Joey