Ferring EU filing for fertility treatment Rekovelle accepted

31 October 2015

Privately-held Swiss firm Ferring Pharmaceuticals said Friday that the Marketing Authorization Application filing for Rekovelle (follitropin delta) has been accepted for review by the European Medicines Agency.

Rekovelle is a novel human recombinant follicle-stimulating hormone (rhFSH) intended for controlled ovarian stimulation (COS) in women undergoing assisted reproductive technology (ART) therapy such as in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI).The submission is supported by comprehensive data from the Phase III ESTHER trials (Evidence-based Stimulation Trial with Human rFSH in Europe and Rest of World) involving 1,326 patients from 37 fertility clinics in 11 countries.

The company expects to launch the drug in the European markets in the second half of 2016, chief scientific officer Per Falk recently told The Pharma Letter in an exclusive interview (TPL September 23).

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