Mitsubishi Tanabe Pharma America announced that the FDA has accepted the New Drug Application (NDA) resubmission for investigational ND0612, a 24-hours/day, continuous, subcutaneous (SC) infusion of liquid levodopa/carbidopa (LD/CD), for the treatment of motor fluctuations in people living with Parkinson's disease (PD). The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date in the fourth quarter of 2025.
"The FDA's acceptance of the NDA for ND0612 is a critical milestone that brings us one step closer to delivering a potential therapeutic option for people with Parkinson's disease who continue to experience disruptive motor fluctuations," said Yasutoshi Kawakami, President, MTPA. "This progress is a testament to MTPA's ongoing efforts in support of individuals in the U.S. impacted by this progressive neurodegenerative disorder."
The NDA is supported by data from the pivotal, Phase 3, multi-center, randomized, double-blind double-dummy (DBDD) 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) of ND0612, with some study participants in their eighth year of follow-up.
NeuroDerm, Ltd., a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC) based in Israel, led the clinical development of ND0612. If approved by the FDA, MTPA will commercialize ND0612 in the U.S.
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