The Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) for relugolix in combination with estradiol and norethindrone acetate (Myfembree®) for the management of moderate to severe pain associated with endometriosis.
The new Prescription Drug User Fee Act (PDUFA) target date is August 6, 2022. The FDA extended the action date to review additional information regarding bone mineral density.
The sNDA submission includes data from the phase 3 SPIRIT 1 (ClinicalTrials.gov Identifier: NCT03204318) and SPIRIT 2 (ClinicalTrials.gov Identifier: NCT03204331) trials, as well as an open-label extension study (ClinicalTrials.gov Identifier: NCT03654274).
Findings showed that treatment with relugolix combination therapy was associated with clinically meaningful reductions in dysmenorrhea and non-menstrual pelvic pain. The SPIRIT 1 and 2 studies also met key secondary endpoints including reduction in dyspareunia and improvement on the Endometriosis Health Profile-30 (EHP-30) pain score.
“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, Chief Medical Officer of Myovant Sciences, Inc. “We will continue to work closely with the FDA to support the ongoing review of the sNDA.”
Myfembree is currently approved for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women.
Myovant Sciences and Pfizer provide update on supplemental New Drug Application (sNDA) for Myfembree® for the management of moderate to severe pain associated with endometriosis. News release. Myovant Sciences, Inc. Accessed May 6, 2022. https://www.globenewswire.com/news-release/2022/05/06/2437672/0/en/Myovant-Sciences-and-Pfizer-Provide-Update-on-Supplemental-New-Drug-Application-sNDA-for-MYFEMBREE-for-the-Management-of-Moderate-to-Severe-Pain-Associated-With-Endometriosis.html