Sanofi-Aventis' Ciltyri delayed as FDA wants more info

17 September 2009

The US Food and Drug Administration has issued a complete response letter regarding the French drug major Sanofi-Aventis's New Drug Application for Cilytri (eplivanserin), thus delaying approval in the USA of the investigational drug. Eplivanserin was reviewed as a potential treatment for patients with chronic insomnia characterized by difficulties with sleep maintenance.

Sanofi-Aventis is currently reviewing the content of the complete response letter, in which the FDA has requested additional information regarding the benefit-risk of the drug. The company says it will contact the agency in the coming days to request a meeting to discuss what steps and data would be needed for approval.

Eplivanserin, discovered and developed by Sanofi-Aventis, is a serotonin type 2 A receptor antagonist an,d unlike benzodiazepine-receptor agonists (BzRAs), has no affinity for GABA receptors. It has been studied in a clinical development program including nearly 3,000 patients, the company notes.

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.

Try before you buy

Free

7 day trial access

Take a Free Trial

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

Subscribe Now

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