Ipsen receives priority review for sNDA for Somatuline

1 September 2014

French drugmaker Ipsen (Euronext: IPN) has received priority review for its supplemental New Drug Application from the US Food and Drug Administration for Somatuline Depot (lanreotide) injection. A decision on this submission is expected in the first quarter of 2015.

The drug is designed to treat gastroenteropancreatic neuroendocrine tumors (GEP NETs), which is supported by the results of a Phase III study, which showed Somatuline substantially prolonged time to disease progression or death versus placebo.

The company is seeking priority review status as a drug candidate with the potential to offer a significant improvement in treatment compared to currently-approved options.

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