Biogen`s rare genetic disorder drug gets approval in EU
Biogen`s Skyclarys backed by EU panel for Friedreich`s ataxia
Biogen said it would buy biotech firm Reata Pharmaceuticals for roughly $6.5 .. nnnRead more at: nhttps://health.economictimes.indiatimes.com/news/pharma/biogen-to-buy-reata-for-6-5-bln-to-bulk-up-rare-disease-portfolio/102220586
SKYCLARYS® recently approved in US as the only treatment indicated for patients with Friedreich™s ataxia Proposed acquisition represents meaningful step forward in Biogen™s strategy for...
Plano-based Reata Pharmaceuticals announced Tuesday that Skyclarys, the first Food and Drug Administration-approved treatment for the ultra-rare neuromuscular disease Friedreich’s ataxia, is now available to patients.
PLANO, Texas--(BUSINESS WIRE)--Reata Pharmaceuticals, 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 that the United States Food and Drug Administration (FDA) has approved the Prior Approval Supplement (PAS) to update the drug substance specification for SKYCLARYS® (omaveloxolone), the first and only FDA approved drug for the treatment of Friedreich’s ataxia in adults and adolescents aged 16 years and older. With the approval of the PAS, SKYCLARYS is now available to patients with Friedreich’s ataxia in the United States.
PLANO, Texas--(BUSINESS WIRE)--Reata Pharmaceuticals, 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 Adistration (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 deteration 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.
On Rare Disease Day, Reata celebrated in appropriate fashion with its first drug approval in the company’s 21-year history.
Reata Pharmaceuticals has done its homework in responding to the FDA’s concerns about an application for its nerve disorder drug. But now the biotech has to sit tight for an extra three months while the agency mulls things over.
Reata Pharmaceuticals is facing an FDA wall on its small molecule candidate to treat Friedreich’s ataxia, omaveloxolone. According to the company’s Q2 report, the FDA might still not be sold on the drug.