Acorda Therapeutics has submitted a marketing authorization application to the EMA for its Inbrija levodopa DPI for the treatment of OFF periods in Parkinson’s disease patients, the company said.
The application is supported by data from the Phase 3 SPAN-PD trial, which demonstrated improved motor function in Parksinson’s patients experiencing OFF periods, and data from two long-term safety studies.
In February 2018, Acorda announced that the FDA had accepted a resubmitted NDA for Inbrija with a PDUFA date of October 5, 2018. The original 505(b)(2) NDA was submitted in June 2017, and the FDA issued a refuse-to-file letter in August of that year.
Inbrija, formerly known as CVT-301, was initially developed by Civitas Therapeutics, which was acquired by Acorda in 2014.
Read the Acorda press release.
