Conditional EC approval for Hansa's Idefirix

27 August 2020

The European Commission has granted conditional approval for Idefirix (imlifidase) in highly sensitized kidney transplants patients, says Lund, Sweden-based enzyme specialist Hansa Biopharma (STO: HNSA).

The formal approval by the European Commission was received two months after the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending conditional approval of Idefirix for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor.

"We are very excited about today's decision from the European Commission to approve Idefirix in highly sensitized kidney transplant patients. This is the first approved drug for Hansa Biopharma and will bring hope to the thousands of highly sensitized patients across Europe waiting for a life-saving kidney transplant," says Søren Tulstrup, president and chief executive of Hansa Biopharma.

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