Takeda withdraws application for ramelteon
Japan's Takeda has withdrawn its centralized Marketing Authorization application to the European Medicines Agency (EMEA) for ramelteon 4mg and 8mg tablets.
In its official letter, the company stated that the decision was based on its current plan to consider seeking scientific advice with a view to extending the clinical program, which would address the Agency's questions regarding the medicine's benefit-risk profile.
The ramelteon Marketing Authorization application for the treatment of primary insomnia in adults was submitted to the EMEA in March 2007. In May this year, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion for the drug. Following this, the company requested a re-examination of the decision, which was under review at the time of the withdrawal.
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
Today's issue
Company Spotlight
Copyright © The Pharma Letter 2025 | Headless Content Management with Blaze