Cleveland-based biotechnology and regenerative medicine company Athersys Inc. (Nasdaq: ATHX) announced that its MultiStem cell therapy has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration for potential treatment of acute respiratory distress syndrome, known as ARDS.
The RMAT designation is important because it enables companies “to work closely with the FDA and receive their guidance on expediting development of their products, including providing advice on generating the evidence needed to support approval in an efficient manner,” Athersys said in a news release. RMAT also enables Athersys “to schedule a Type B meeting with the FDA to discuss multidisciplinary strategic development plans, including expediting manufacturing development for commercialization to support priority review and/or accelerated approval,” according to the release.
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Story excerpt provided by Crain’s Cleveland Business.
Originally published September 23, 2020.