The FDA recently announced the acceptance of a supplemental New Drug Application for relugolix 40 mg, estradiol 1 mg, and norethindrone acetate .5 mg in the treatment of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.
Recently, Myovant Sciences and Pfizer Inc announced that the US Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) for relugolix 40 mg, estradiol 1 mg, and norethindrone acetate .5 mg (Myfembree). In the sNDA, they propose updates to the drug’s United States prescribing information based on safety and efficacy data from the phase 3 LIBERTY randomized withdrawal study (NCT03412890).
The study evaluated the medication for treatment of premenopausal women with heavy menstrual bleeding associated with uterine fibroids for up to 2 years.
Uterine fibroids are characterized as noncancerous tumors that develop in or on the muscular walls of the uterus, according to the press release announcing the sNDA acceptance. These fibroids are among the most common reproductive tract tumors in women. Although benign, uterine fibroids can cause debilitating symptoms like heavy menstrual bleeding, pain, increased abdominal girth, bloating, urinary frequency or retention, constipation, pregnancy loss, and, in some cases, infertility.
“Heavy menstrual bleeding is the most common symptom affecting women with uterine fibroids that can impact their daily life and activities over a long period of time,” said Juan Camilo Arjona Ferreira, MD, chief medical officer of Myovant Sciences, Inc, in the release. “We are pleased to submit these study results to the FDA as they show the value MYFEMBREE can potentially have on treating women’s uterine fibroid symptoms long term.”
The FDA has set the sNDA under PDUFA target action date for January 29, 2023.
Myovant Sciences and Pfizer announce FDA acceptance of supplemental new drug application for Myfembree. Pfizer Inc. Press release. Published June 2, 2022. Accessed June 13, 2022. https://www.pfizer.com/news/press-release/press-release-detail/myovant-sciences-and-pfizer-announce-fda-acceptance-1