Acorda Therapeutics (NSDQ:ACOR) submitted a marketing authorization application to the European Medicines Agency for its inhaled Parkinson’s disease therapy, Inbrija, according to the Ardsley, N.Y.-based company.
The investigational drug is designed to treat people with Parkinson’s disease who are experiencing “off” periods, or a re-emergence of symptoms.
Acorda’s marketing application for Inbrija includes data from a Phase III safety and efficacy trial and results from two long-term safety studies. The late-stage Phase III trial found that people with Parkinson’s disease experiencing “off” periods had statistically significant improvement in motor function after taking Inbrija.
The company is also hoping to land a regulatory win for its inhaled therapy in the U.S. Acorda resubmitted its new drug application for Inbrija in December last year and the FDA announced it would review the bid in February. The agency is set to make a decision regarding Inbrija by October.
ACOR shares were trading at $23.65 apiece in early-morning activity today, up +3.5%.