The US Food and Drug Administration (FDA) has extended the review period for Pfizer and Myovant Sciences’ New Drug Supplement (sNDA) for Myfembree for the management of moderate to severe pain associated with endometriosis.
Myfembree contains 40 mg relugolix, 1 mg estradiol and 0.5 mg norethindrone acetate.
Relugolix lowers estrogen and other hormones produced by the ovaries, estradiol is an estrogen that can reduce the risk of bone loss, and norethindrone acetate is a progestin needed when women with a uterus take estrogen.
The FDA noted that the regulatory agency needs more time to review additional data on bone mineral density that it has sought from companies.
With the latest developments, the FDA has set an extended date for the target date of the Prescription Drug Consumption Act (PDUFA), August 6 this year.
Myovant Sciences Chief Medical Officer Juan Camilo Arhona Ferreira said: “We remain confident in the clinical profile of Myfembree and its potential to become a therapeutic option for the management of endometriosis pain.
“We will continue to work closely with the FDA to support the ongoing review of the sNDA.
Endometriosis is a disease in which tissue identical to the endometrium is present outside the uterine cavity.
Last year, Myfembree was approved by the US FDA for the treatment of severe menstrual bleeding associated with uterine fibroids in premenopausal women with a duration of treatment of up to two years.
This is the first once-daily oral therapy approved for this indication.
The latest development comes after Pfizer reported revenue of $ 25.7 billion in the first quarter (Q1) of 2022 compared to $ 14.5 billion in the first quarter of 2021, showing 82% operating growth.