Biogen: Japan Panel Seeks Additional Data in Aducanumab Review
December 22 2021 - 8:26AM
Dow Jones News
By Michael Dabaie
Biogen Inc. and Eisai Co. said the First Committee on New Drugs
of Japan's Pharmaceutical Affairs and Food Sanitation Council
decided to continue deliberations on the application for approval
of aducanumab in Alzheimer's disease.
The council advises Japan's ministry of health, labor and
welfare.
The NDC is seeking additional data to be submitted as part of
this process. The companies said they will continue to engage with
the Pharmaceuticals and Medical Devices Agency to agree on
additional data requirements.
Biogen and Eisai said they remain committed to bringing
aducanumab expeditiously to patients in Japan. The companies are
collaborating on the global co-development and co-promotion of the
medication.
Write to Michael Dabaie at michael.dabaie@wsj.com
(END) Dow Jones Newswires
December 22, 2021 08:11 ET (13:11 GMT)
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