Mitsubishi Tanabe Resubmits NDA for Parkinson’s Combo

FDA has accepted for review a Mitsubishi Tanabe Pharma America NDA resubmission for investigational ND0612, a continuous, subcutaneous infusion of liquid levodopa/carbidopa (LD/CD) for treating motor fluctuations in people living with Parkinson's disease (PD). The agency set a user fee review action target date for the fourth quarter.

The resubmission addresses concerns raised in a 6/2024 complete response letter and subsequent Type A meeting with the agency that requested “additional safety information on the carbidopa ingredient of ND0612, as well as additional information on product quality, device, and manufacturing site inspections,” according to the company.

The submission is supported by data from the pivotal, Phase 3, multi-center, randomized, double-blind BouNDless trial (NCT04006210), which evaluated the effectiveness and safety of ND0612 in people with PD experiencing motor fluctuations, as well as long-term safety data from the ongoing Phase 2b BeyoND study (NCT02726386).