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Reata Pharmaceuticals’ Skyclarys (omaveloxolone) Receives the US FDA’s Approval for the Treatment of Friedreich’s Ataxia

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Reata Pharmaceuticals

Reata Pharmaceuticals’ Skyclarys (omaveloxolone) Receives the US FDA’s Approval for the Treatment of Friedreich’s Ataxia

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  • The US FDA has approved Skyclarys for adults & adolescents aged ≥16yrs. with Friedreich’s ataxia. The approval was based on the (MOXIe) part 2 trial & post hoc propensity-matched analysis of the OLE (MOXIe) trial evaluating omaveloxolone (150mg) vs PBO
  • The (MOXIe) part 2 trial results showed lower mFARS scores over PBO @48wk., the PBO-corrected difference b/w the 2 groups were -2.41 points. In the OLE trial, improved mFARS scores after 3yrs. over untreated patients from FA-COMS natural history study
  • The company launched a patient services program & provides access to patients for Skyclarys treatment. The product is expected to be available in Q2’23 and received ODD, FTD & RPDD from the US FDA; ODD from the EC for Friedreich’s ataxia

Ref: Businesswire | Image:  Reata Pharmaceuticals

Related Post:- Reata Reports Results of Omaveloxolone in P-II MOXIe Registrational Study for Patients with Friedreich's Ataxia

Click here to­ read the full press release 

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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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