The U.S. Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) from Pfizer Inc. (NYSE:PFE) and its partner Myovant Sciences (NYSE:MYOV) 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.
The regulatory agency has set a new goal date of August 6, 2022.
Camilo Arjona Ferreira, Chief Medical Officer of Myovant Sciences, said, “We remain confident in the clinical profile of MYFEMBREE and its potential to become a therapeutic option for the management of endometriosis-associated pain, We will continue to work closely with the FDA to support the ongoing review of the sNDA”.
Earlier in April 2022, FDA provided notice to Pfizer and Myovant that the agency identified deficiencies that preclude discussion of labeling and/or post-marketing requirements and commitments at that time.
In the year 2021, MYFEMBREE® was approved in the U.S. for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.
Pfizer shares are trading down at $48.21 in the pre market session
