Myovant and Pfizer’s Myfembree Receive the US FDA’s Approval for the Treatment of Pain Associated with Endometriosis
Shots:
- 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
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
