FDA sign

Less than one month after the U.S. Food and Drug Administration raised concerns about the supplemental New Drug Application for Pfizer and Myovant Sciences’ Myfembree (relugolix), the regulatory agency extended the review period to Aug. 6. The initial approval review date was May 6.

A group of scientists from the Nuffield Department of Women’s & Reproductive Health at Oxford University may have found a potential key to finally treating endometriosis, a disease that affects around 176 million women worldwide. 

Findings from a Phase III long-term extension study show a once-daily therapy consisting of relugolix with estradiol and norethindrone acetate leads to clinically meaningful reductions in menstrual pain and non-menstrual pelvic pain over one year in women with endometriosis.

Myovant announced topline results from SPIRIT 1, the second Phase III trial of once-daily relugolix combination therapy in women with pain linked with endometriosis.

Myovant saw positive results in the first of two Phase III studies of a combination therapy for pain associated with endometriosis. The Switzerland-based company said the SPIRIT-2 study met the co-primary efficacy endpoints and six key secondary endpoints.

Switzerland-based Myovant announced an 88 percent one-year response rate in the positive Phase III LIBERTY extension study of once-daily, oral relugolix combination therapy in women with heavy menstrual bleeding associated with uterine fibroids.