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Mitsubishi Tanabe Pharma Reports US FDA Acceptance of NDA for Edaravone (MT-1186) for the Treatment of ALS

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Mitsubishi Tanabe Pharma Reports US FDA Acceptance of NDA for Edaravone (MT-1186) for the Treatment of ALS

Shots:

  • The NDA is based on the P-III (RADICAVA IV) trial evaluating the safety & tolerability of edaravone vs Radicava IV formulation in 185 patients with ALS along with 7 P-I clinical pharmacology studies to evaluate PK, safety, drug-drug interactions, dosing, bioavailability & bioequivalence in ALS patients with/out PEG/NGT
  • Additionally, edaravone has been developed to have a similar clinical profile compared to the IV formulation of Radicava (edaravone)
  • The US FDA has accepted the application for priority review with an anticipated PDUFA date of May 12, 2022. Edaravone is an investigational oral formulation & received the US FDA’s approval for the treatment of ALS in May 2017

Ref: PR Newswire | Image: PR Newswire

Click here to­ read the full press release 

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