Myfembree approved for heavy menstrual bleeding associated with uterine fibroids

27 May 2021

Myovant Sciences (NYSE: MYOV) and Pfizer (NYSE: PFE) have announced that the US Food and Drug Administration (FDA) has approved Myfembree (relugolix/estradiol/norethindrone acetate), the first once-daily treatment for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women, with a treatment duration of up to 24 months.

Under the terms of their previously announced collaboration, Myovant and Pfizer will jointly commercialize the product in the USA. The tablet is expected to be available next month.

"The approval of Myfembree represents the second FDA product approval for Myovant in less than one year"Ayman Al-Hendy, professor of obstetrics and gynecology, University of Chicago, and LIBERTY Program steering committee member, said: “With Myfembree, we can offer women with uterine fibroids a non-invasive treatment that provides clinically-meaningful symptom relief for heavy menstrual bleeding with one pill, once-a-day.

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