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Reata Pharmaceuticals has announced the company's first quarter financial results and provided an update on their clinical development programs.

Updates on their FA program include:

- They completed submission of an New Drug Application (NDA) to the U.S Food and Drug Administration (FDA) for Omaveloxolone for treatment for patients with Friedreich's Ataxia in March.

Reata CEO, Warren Huff states, “. . .we are looking forward to working with the FDA on its review of our NDA throughout this year. If approved, we are preparing to be in a position to launch this important drug by early 2023.”

- This program has received Fast Track Designation, Orphan Drug Designation, and Rare Pediatric Disease Designation.

- They have secured an agreement on their Pediatric Investigation Plan with the European Medicines Agency (“EMA”) Pediatric Committee.

- They are continuing to complete the regulatory procedures and submissions required prior to filing a Marketing Authorization Application (“MAA”) in Europe for approval of omaveloxolone for the treatment of patients with Friedreich’s ataxia. They plan to submit an MAA to the EMA in the fourth quarter of 2022.

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