According to the Friedreich's Ataxia Research Alliance, there are several potential competitors in the pipeline for FA treatment, including one Phase 3 candidate and a few in Phase 2. At first glance, the competitive risk to Reata's Skyclarys seems relatively low, but it's essential to remain cautious as the landscape can change.
PTC Therapeutics' Phase 3 candidate, vatiquinone, failed to meet its Phase 2 study endpoints related to FA. Phase 3 data is expected in Q2 2023. Leriglitazone did not meet endpoints in a Phase 2 proof-of-concept study. The HIV antiviral drug, etravirine, demonstrated increased frataxin levels in FA patient-derived cells but is awaiting Phase 2 clinical trial results. Most other drugs are in Phase 1, while gene therapy is in pre-clinical development.
Thursday, March 23, 2023
Skyclarys' Positive Reception By FDA And Medical Community Bolsters Reata's Future
Seeking Alpha. Mar. 23, 2023.
Reata Pharmaceuticals recently received FDA approval for Skyclarys, the first drug approved to treat Friedreich's ataxia (FA) in adults and adolescents aged 16 years and older.
Skyclarys is expected to experience significant utilization among FA patients, with a potential peak annual revenue between $800 million and $1 billion in the US alone.
