Acorda Therapeutics files MAA with EMA for Inbrija for symptoms of OFF periods in people with Parkinson's disease.

Acorda Therapeutics, Inc. announced that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Inbrija. Acorda is seeking marketing approval in the European Union for Inbrija an investigational inhaled levodopa treatment for symptoms of OFF periods in people with Parkinson's disease taking a carbidopa/levodopa regimen.

The MAA for Inbrija includes clinical data from the Inbrija Phase III safety and efficacy trial (SPAN-PD), as well as the results from two long-term safety studies in people with Parkinson's. Findings from these studies support the submission of Inbrija for use on an as needed basis to address symptoms of OFF periods. The primary endpoint from the Phase III study of Inbrija showed a statistically significant improvement in motor function in people with Parkinson's disease experiencing OFF periods. Data was presented at the International Congress of Parkinson's Disease and Movement Disorders (MDS) in June 2017.

Comment: The FDA is currently reviewing a New Drug Application for Inbrija and has set an action date of October 5, 2018 under the Prescription Drug User Fee Act (PDUFA).