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May 26, 2022
Reata Pharmaceuticals announced today the FDA have granted their Omaveloxolone application ‘Priority Review’ designation. This means the FDA will review their application for regulatory approval within 8 months rather than the usual 12 months. Omaveloxolone is a drug being tested for the treatment of FA.
For more information, read the press release.
May 23, 2022
Biohaven Pharmaceuticals reported top-line results of its phase 3 clinical trial of troriluzole, an investigational drug for patients with SCA. While we share in your disappointment that the drug did not meet its primary endpoint in the overall SCA population, there is much more to this story than just that headline. Further analysis by SCA type suggests a positive treatment effect in patients with SCA3, the most common form of SCA. There was also a reduction in the relative risk of falls in troriluzole-treated patients with all types of SCA included in the trial versus the placebo group.
We are pleased that Biohaven will be presenting this data to the FDA as soon as possible. “The f-SARA change in the SCA3 troriluzole treated group is compelling,” stated Dr. Susan Perlman, Director of Ataxia Clinic and Neurogenetics Clinical Trials at the David Geffen School of Medicine at UCLA. “Given the excellent safety profile of troriluzole, and the fact that there are no approved treatment options for patients with this devastating neurodegenerative disorder, I am thrilled for my patients that Biohaven is planning to engage with the FDA to potentially move this program forward.”
For more information, read the press release.
May 10, 2022
Biohaven Pharmaceuticals, the company running a phase three clinical trial of troriluzole for the treatment of Spinocerebellar Ataxia, has been purchased by Pfizer. Pfizer is buying Biohaven’s big migraine drug, NURTEC. Then a new publicly traded company will be created that will retain Biohaven’s pipeline for neurological and other disorders. NAF has confirmed with the company that the troriluzole trial remains on track and will report topline results in mid-2022.
For more information, read the press release.
May 10, 2022
Reata Pharmaceuticals recently announced that the FDA has granted Fast Track Designation, Orphan Drug Designation, and Rare Pediatric Disease Designation to omaveloxolone for the treatment of Friedreich’s Ataxia.
For more information, read the press release.
November 8, 2021
Seelos Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, announced today that the FDA has accepted Seelos’ Investigation New Drug (IND) application to study SLS-005 (trehalose injection, 90.5 mg/mL for intravenous infusion) for the treatment of Spinocerebellar Ataxia (SCA). The FDA has also granted the program Fast Track designation.
For more information, read the press release.
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