Acorda Therapeutics announced that the European Medicines Agency, or EMA, has completed formal validation of Acorda’s Marketing Authorization Application, or 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. The EMA review of the MAA will be according to standard timelines, with an opinion of the Committee for Medicinal Products for Human Use, or CHMP, expected within 210 days. After the adoption of a CHMP opinion, a final decision regarding the MAA is carried out by the European Commission. The FDA is currently reviewing a new drug application for Inbrija and has set an action date of October 5 under the Prescription Drug User Fee Act.
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