Mesoblast Limited received RMAT designation for its Rexlemestrocel-L from US FDA

Feb 09, 2023

On February 9, 2023, Mesoblast Limited (ASX: MSB) announced that their prestigious product, Rexlemestrocel-L, has earned the Regenerative Medicine Advanced Therapy (RMAT) distinction from the US Food and Drug Administration's Office of Tissues and Advanced Therapies. This distinction is given to treatments aimed at addressing chronic low back pain caused by disc degeneration, with hyaluronic acid as the delivery method for injections into the lumbar disc. The RMAT designation was created to expedite the development of regenerative medicine treatments that have the potential to cure, modify, or treat serious illnesses or conditions.

With the RMAT designation, rexlemestrocel-L is eligible for benefits such as a rolling review and a priority review when a Biologics License Application is filed. Mesoblast boasts a robust and extensive global intellectual property portfolio that provides protection until 2041 in key markets. The company's proprietary methods for manufacturing cellular medicines yield a high volume of cryopreserved, ready-to-use products.

 

 

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