The approval was based on the 1yr. efficacy & safety data incl. P-III (SPIRIT 1 & 2) trials evaluating Myfembree vs PBO in 1200+ women with pain associated with endometriosis
The P-III (SPIRIT 1 & 2) trial met their co-primary EPs i.e., 75% of women reduced dysmenorrhea in both studies vs 27% & 30% in PBO @24wk. In non-menstrual pelvic pain, 59% & 66% vs 40% & 43% achieved a reduction while loss of mean bone mineral density of ≤1% from baseline @1yr.; 19.7% had losses >3% in OLE study
Myfembree is expected to be available shortly. The companies launched a patient support program & provide access to patients for Myfembree treatment & also offers support services, incl. insurance benefits, prior authorization support, co-pay support & patient assistance
Ref: Pfizer | Image: Pfizer
