FDA Delays sNDA Decision for Pfizer-Myovant Endometriosis Pain Drug Myfembree

The FDA has pushed back its decision date on Pfizer’s and Myovant Sciences’ supplemental New Drug Application (sNDA) for Myfembree (relugolix, estradiol and norethindrone acetate) from May 6 to Aug. 6.

Myfembree is currently FDA-approved for the treatment of premenopausal women with heavy menstrual bleeding associated with uterine fibroids. In their sNDA, the two companies hope to expand the drug’s indication to include the management of moderate-to-severe pain that is associated with endometriosis.

Earlier this year, the agency notified the companies of deficiencies in the application that would preclude labeling of Myfembree for the indication but said a final decision had not been made and that the application was still under review.

“We remain confident in the clinical profile of Myfembree and its potential to become a therapeutic option for the management of endometriosis-associated pain,” said Juan Camilo Arjona Ferreira, Myovant’s chief medical officer.