- Biogen (NASDAQ:BIIB) has submitted a Japanese New Drug Application (J-NDA) to the Ministry of Health, Labor and Welfare (MHLW) for aducanumab (BIIB037), an investigational therapy for Alzheimer’s disease.
- The Japanese regulatory authority will review the application through the standard review process.
- In addition, aducanumab is under Priority Review with the FDA, with a PDUFA action date of March 7, 2021 and is also under review with the EMA.
- Biogen licensed aducanumab from Neurimmune. Since October 2017 Biogen and Eisai (OTCPK:ESALF) have collaborated on the commercialization of aducanumab globally.
- https://seekingalpha.com/news/3643160-biogen-files-new-drug-application-for-aducanumab-in-japan
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