EMA validates Gilead's lenacapavir MAA for HIV-1 patients with limited options

20 August 2021

Gilead Sciences (Nasdaq: GILD) has announced that the company’s Marketing Authorization Application (MAA) for lenacapavir, a long-acting HIV-1 capsid inhibitor, has been fully validated and is now being evaluated by the European Medicines Agency (EMA).

The proposed indication is for the treatment of HIV-1 infection, in combination with other antiretrovirals, in adults with multidrug resistant HIV-1 infection who are currently on a failing antiretroviral treatment regimen due to resistance, intolerance or safety considerations.

"Has the potential to be transformative for people with multi-drug resistant HIV"This application will be reviewed by the EMA’s Committee for Medicinal Products for Human Use under the centralized licensing procedure for all 27 member states of the European Union, as well as Norway, Iceland and Liechtenstein.

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