Myovant Sciences (NYSE: MYOV) and Pfizer (NYSE: PFE) have announced an update on the Supplemental New Drug Application (sNDA) for MYFEMBREE (relugolix 40 mg, estradiol 1 mg and norethindrone acetate 0.5 mg) for the management of moderate to severe pain associated with endometriosis.
In accordance with the ongoing review of the application, on April 6, 2022, the U.S. Food and Drug Administration (FDA) provided notice to the companies that the agency identified deficiencies that preclude discussion of labeling and/or post-marketing requirements and commitments at this time. The FDA did not provide additional detail. The FDA noted that the letter does not reflect a final decision on the pending sNDA and that the application is still under review, Pfizer said.
MYFEMBREE (relugolix, estradiol, and norethindrone acetate) is the first once-daily oral treatment for heavy menstrual bleeding associated with uterine fibroids in premenopausal women approved by the U.S. Food and Drug Administration, with a treatment duration of up to 24 months. MYFEMBREE contains relugolix, which reduces the amount of estrogen (and other hormones) produced by ovaries, estradiol (an estrogen) which may reduce the risk of bone loss, and norethindrone acetate (a progestin) which is necessary when women with a uterus (womb) take estrogen, Pfizer explained in its press release.
Myovant and Pfizer noted that they will continue to work with the FDA to determine next steps with the application.