FDA Extends PDUFA Timeline for MYFEMBREE Endometriosis Application

The US Food and Drug Administration (FDA) has extended the period to review the supplemental New Drug Application (sNDA) for relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg (MYFEMBREE) for managing moderate-to-severe endometriosis pain.

The delay, announced by applicant companies Myovant Sciences and Pfizer late last week, will grant the FDA more time to review additionally requested information from the application regarding bone mineral density impact with the combination therapy. As such, the new PDUFA date for the sNDA will be August 6 of this year.

Myovant chief medical officer Juan Camilo Arjona Ferreira stated the company’s intent to continue working with the FDA during the ongoing sNDA review.

“We remain confident in the clinical profile of MYFEMBREE and its potential to become a therapeutic option for the management of endometriosis-associated pain,” Ferreira said in a statement.

The relugolix/estradiol/norethindrone acetate combination therapy was originally approved by the FDA for the treatment of menstrual bleeding associated with uterine fibroids for up to 24 months in premenopausal women. It is the first once-daily oral therapy to receive such an indication from the FDA.

The agent additionally carries a Boxed Warning regarding risk of thromboembolic disorders and vascular events among treated patients, as well as a contraindication in women with current or history of thrombotic or thromboembolic disorders, as well as women at risk of such issues.

As previously explained to HCPLive by Maria Sophocles, MD, medical director of Women’s Healthcare of Princeton, endometriosis is capable of “wreaking havoc on the daily lives of reproductive-age women.”

“Like fibroids, endometriosis is a large burden of pathology for American women, in terms of days of lost work and school pain, undiagnosed pain, infertility,” Sophocles said at the time. “And so, it's important that we try to treat it. It's been treated medically, it's still treated medically and surgically, but the focus is now on medical treatment, on non-invasive treatment suppressing the endometrial implants.”

Relugolix is among the GnRH receptor agonist drug class that is among the leading agents for treating endometriosis and uterine fibroid pain. As explained to HCPLive by Erica Marsh, MD, MSCI, professor of Obstetrics and Gynecology at University of Michigan Medical School last year, the steadily rolled-out agonist drug class may have a specific, but beneficial, role in complementing the armament of endometriosis and fibroid pain management.

“I think it’s been nice as somebody who focuses on helping someone with fibroids by offering them something new that’s on the market, but also make sure they’re counseled on our other options that we would maybe start with,” Marsh said.