Research & Development
Mitsubishi Tanabe Pharma America's RADICAVA ORS receives US FDA approval
16 May 2022 -

Mitsubishi Tanabe Pharma America, Inc. (MTPA), a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation's (MTPC) 100% owned US holding company, Mitsubishi Tanabe Pharma Holdings America, Inc, announced on Friday that it has received approval from the United States Food and Drug Administration (FDA) for its RADICAVA ORS (edaravone), the oral form of edaravone, intended to treat amyotrophic lateral sclerosis (ALS).

The company said that the product provides the same efficacy as RADICAVA (edaravone), an FDA-approved intravenous (IV) treatment shown in a pivotal trial to support reducing the loss of physical function in ALS. It is specifically formulated for patients with ALS and provides a flexible administration option (taken orally or via feeding tube) with a small, five mL dose, a portable bottle, an oral dosing syringe and no requirement for patients to refrigerate or reconstitute before taking.

Tulio Bertorini, M.D., professor of Neurology, The University of Tennessee Health Science Center, said, 'ALS is a progressive disease that, due to its heterogenous nature, impacts patients at different rates with varying symptoms. Therefore, it is crucial that patients have treatment and formulation options that accommodate their own unique needs, and RADICAVA ORS provides HCPs who have prescribed their ALS patients edaravone with an alternate delivery option.'

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