Japan's regulator delays Aduhelm decision, as US medics call for its market removal
US biotech Biogen (Nasdaq: BIIB) and Japanese partner Eisai (TYO: 4523) today announced that the First Committee on New Drugs (NDC) of the Pharmaceutical Affairs and Food Sanitation Council, which advises the Japanese Ministry of Health, Labor and Welfare (MHLW), has decided to continue deliberations on the application for the manufacturing and marketing approval of Aduhelm (aducanumab) for the treatment of Alzheimer’s disease.
The news pushed Eisai’s share 8% lower to 6,477 yen by lose of trading, while Biogen was barely changed in pre-market activity.
The NDC is seeking additional data to be submitted as part of this process. The companies will continue to actively engage with the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan to agree on additional data requirements. Biogen and Eisai stress that they remain committed to bringing aducanumab to patients in Japan expeditiously.
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
Free
7 day trial access
- All the news that moves the needle in pharma and biotech
- Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
- Receive The Pharma Letter daily news bulletin, free forever.
Become a subscriber
£820
Or £77 per month
- Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
- Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
- Daily roundup of key events in pharma and biotech.
- Monthly in-depth briefings on Boardroom appointments and M&A news.
- Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
More on this story...
Today's issue
Company Spotlight
More Features in Biotechnology
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze