Acorda Therapeutics, Inc. issued the following announcement on May 29.
Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that the European Medicines Agency (EMA) has completed formal validation of Acorda’s Marketing Authorization Application (MAA) for INBRIJA. INBRIJA is an investigational inhaled levodopa treatment for symptoms of OFF periods in people with Parkinson’s disease taking a carbidopa/levodopa regimen. The INBRIJA MAA was submitted to the EMA on March 23, 2018.
The EMA review of the MAA for INBRIJA will be according to standard timelines, with an opinion of the Committee for Medicinal Products for Human Use (CHMP) expected within 210 days (plus any clock-stops for the applicant to provide answers to questions which may arise during the review). After the adoption of a CHMP opinion, a final decision regarding the MAA is carried out by the European Commission.
The U.S. Food and Drug Administration (FDA) is currently reviewing a New Drug Application for INBRIJA and has set an action date of October 5, 2018 under the Prescription Drug User Fee Act (PDUFA).
Original source can be found here.
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