TANABEMITSUBISHI PHARMACEUTICAL CO., LTD. (Headquarters: Chuo-ku, Osaka, Representative Director: Akihiro Tsujimura, hereinafter referred to as "Tanabe Mitsubishi Pharma") has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the application for approval of ND0612, which is being developed by its wholly owned subsidiary, NeuroDerm Ltd. (Headquarters: Rehovot, Israel, CEO: Kenji Isshiki), for Parkinson's disease with daily fluctuations in motor symptoms in the United States. Tanabe Mitsubishi Pharma Group is currently reviewing the contents of the CRL and plans to determine the next steps in the United States in close cooperation with the FDA.*Received.
The Tanabe Mitsubishi Pharma Group is currently reviewing the contents of the CRL and plans to determine the next steps in the United States in close cooperation with the FDA.
- *A complete response letter is issued by the FDA when the current application does not lead to approval.
About ND0612
ND0612 is a treatment that liquifies levodopa and carbidopa and continuously subcutaneously injects patients with an infusion pump for 24 hours. There is an unmet medical need for stable clinical effects due to changes in levodopa blood concentrations in oral levodopa/carbidopa therapy. By continuously subcutaneously injecting levodopa/carbidopa for 24 hours, ND0612 is expected to reduce daily fluctuations in motor symptoms in Parkinson's patients by stabilizing levodopa blood concentrations more consistently than conventional oral therapy and improving its pharmacokinetic profile.
About NeuroDerm Ltd.
NeuroDerm Ltd. is an Israeli pharmaceutical company that has excellent technical development capabilities in combining new dosage research and medical devices for central nervous system treatments. Through innovative technology, it aims to reduce the burden of treatment and improve the quality of life for patients and their families. Tanabe Mitsubishi Pharma has expanded its pipeline in the central nervous system focus area by making it a wholly owned subsidiary in October 2017.www.neuroderm.com
Contact
Mitsubishi Chemical Group Public Relations Department Osaka Communication Department TEL: 06-6205-5119