According to Acorda Therapeutics, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion regarding Inbrija inhaled dry powder levodopa for the treatment of motor fluctuations (OFF periods) in Parkinson’s disease patients treated with a levodopa/dopa-decarboxylase inhibitor. The marketing authorization application was submitted under the centralized licensing procedure in March 2018.
In the US, the FDA approved Inbrija in December 2018, and Acorda launched the DPI through specialty pharmacies in February 2019. Inbrija is based on the ARCUS dry powder inhalation platform, which Acorda acquired when it acquired Civitas Therapeutics in 2014.
Acorda President and CEO Ron Cohen commented, “We are delighted that Inbrija has achieved this important milestone, and look forward to the EC’s final decision later this year. There are approximately 1.2 million people in the EU living with Parkinson’s. We estimate that 40% of these individuals experience OFF periods, which are considered extremely disruptive. Acorda is currently evaluating partnering opportunities to commercialize Inbrija in Europe.”
Read the Acorda Therapeutics press release.
