Novagali withdraws EU Vekacia MAA
Ivry, France-based emerging ophthalmic drug firm Novagali Pharma has withdrawn its application for a centralized Marketing Authorization Application to the European Medicines Agency (EMEA) for Vekacia (ciclosporin) 0.05% eye drops for vernal keratoconjunctivitis.
At the time of the withdrawal, it was under review by the EMEA's Committee for Medicinal Products for Human Use (CHMP). In its official letter, the company stated that the withdrawal was based on the CHMP's view that the submitted data did not allow the Committee to conclude on a positive benefit-risk balance for Vekacia at that time.
The French firm recently secured 15.0 million euros ($19.0 million) in a new financing round with the participation of existing investors to help fund its portfolio of drugs including Vekacia (Marketletter October 13).
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