Reata Pharmaceuticals Announces FDA Filing Acceptance of SKYCLARYS® (Omaveloxlone) NDA Prior Approval Supplement

Jun 16, 2023

Reata+Pharmaceuticals%2C+Inc. (Nasdaq: RETA) (“Reata,” the “Company,” “our,” “us,” or “we”), a global biopharmaceutical company focused on developing and commercializing novel therapies for patients with severe diseases, announced today that the U.S. Food and Drug Administration (FDA) accepted for filing the Prior Approval Supplement (PAS) to update the drug substance specification for SKYCLARYS^® (omaveloxolone). As per the US Code of Federal Regulation, the filing means FDA has made a threshold determination that the PAS is sufficiently complete to permit a substantive review. As previously communicated, the PAS is being reviewed under expedited Priority Review with a target action date of mid-August 2023.

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