FDA approves Pfizer, Myovant’s uterine fibroids drug Myfembree

The US Food and Drug Administration (FDA) has approved Pfizer and Myovant’s uterine fibroids drug Myfembree for the management of heavy menstrual bleeding.

Specifically, Myfembree (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) has been authorised for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women, with a treatment duration of up to 24 months.

In the Phase III LIBERTY studies, 72.1% and 71.2% of women in the Myfembree treatment groups achieved the responder criteria, compared with 16.8% and 14.7% of women in the placebo groups at week 24, respectively.

Response was defined as a menstrual blood loss volume of less than 80 mL and a 50% or greater reduction from baseline in menstrual blood loss during the last 35 days of treatment.

In addition, women being treated with Myfembree experienced reductions of 82.0% and 84.3% in menstrual blood loss from baselines, respectively.

“Myfembree’s approval is a testament to the shared commitment between Myovant and Pfizer to support women living with uterine fibroids,” said Nick Lagunowich, global president, internal medicine at Pfizer.

“We are excited to offer this new treatment option which will help provide much needed symptom relief with the convenience of an oral, once-daily tablet,” he added.

“The FDA approval of Myfembree represents a significant milestone in expanding treatment options for uterine fibroids, a chronic and debilitating disease for many women in the US,” commented Ayman Al-Hendy, member of the LIBERTY programme steering committee.