The FDA has accepted Acorda Therapeutics’ revised NDA for Inbrija inhaled levodopa for the treatment of symptoms associated with OFF periods in Parkinson’s disease in patients taking carbidopa/levodopa, the company said. The PDUFA target date is October 5, 2018.
In August 2017, the FDA issued a refuse-to-file letter in response to Acorda’s initial 505(b)(2 ) NDA for the Inbrija DPI, which was submitted in June 2017. The FDA did not request any additional clinical data for resubmission of the NDA.
Acorda Chief Medical Officer Burkhard Blank said, “OFF periods greatly disrupt the lives of people living with Parkinson’s, and there is a significant need for new treatments in this community. We are excited about the potential to bring this highly innovative treatment option to people living with Parkinson’s, and look forward to working with the FDA throughout the review process.”
Read the Acorda Therapeutics press release.
