Once-daily endometriosis treatment gets FDA approval

Pfizer and Myovant Sciences will co-market the drug that is now available to the public.

Myfembree is a treatment that reduces heavy menstrual bleeding due to uterine fibroid in premenopausal women. 

Myfembree is an 8 mm-diameter pill that needs to be taken once a day for no longer than a 24 months period. The pill contains relugolix, estradiol and norethindrone acetate.

Relugolix helps reduce the amount of estrogens in the body to help reduce menstrual bleeding.

Estradiol is an oestrogen which can reduce the risk of bone loss caused by taking relugolix alone.

Norethindrone acetate is a progestin which can protect the uterus from the effect of taking oestrogens alone.

The approval of Myfembree is supported by one-year safety and efficacy data which found that the pill reduces menstrual pain and non-menstrual pelvic pain in premenopausal women with endometriosis.

“Endometriosis is a painful, chronic disease with limited therapies to manage symptoms,” said Juan Camilo Arjona Ferreira, chief medical officer of Myovant Sciences. “The new Myfembree indication helps advance our mission to redefine care for women by helping address a disease with high unmet need, giving women and physicians a new meaningful treatment option to manage moderate to severe pain associated with endometriosis.”

FDA approval of a drug means that data on the drug’s effects have been reviewed by CDER, and the drug is determined to provide benefits that outweigh its known and potential risks for the intended population.

The drug approval process includes an analysis of the target condition and available treatments, an assessment of benefits and risks from clinical data and an evaluation of strategies for managing risks.

This FDA approval comes at an optimal time as there is still no current cure for endometriosis. Current treatments include painkillers and hormone medicines and contraceptives. 

On the other hand, women who live with endometriosis can have an operation to remove part or all of the organs affected by endometriosis or a surgery to cut away patches of he endometriosis tissue.