After a delay, the United States Food and Drug Administration has approved the Pfizer and Myovant drug Myfembree. Myfembree is a once-a-day therapy for the management of moderate to severe pain associated with endometriosis in pre-menopausal women.
Previously, the FDA flagged deficiencies in the drug application ahead of its original May 6 decision date. Since then, in a July quarterly earnings release, Myovant stated that pending the green light, the companies would roll out the drug in its new use this month.
“This approval is an important milestone reflecting Pfizer and Myovant’s commitment to women’s health in areas of significant unmet need,” said Pfizer Senior Vice President and CEO James Rusnak, M.D., Ph.D. “We look forward to making Myfembree available to women with endometriosis and broadening their options in managing this complex disorder.”
The FDA approval is supported by one year data from the SPIRIT program. Overall, the three SPIRIT studies that were run showed Myfembree reduced menstrual pain and non-menstrual pelvic pain with a loss of mean bone mineral density of less than 1% from baseline through one year of treatment.
“This newly approved option for patients with pain from endometriosis offers the convenience of one pill taken once daily with a mean change in bone mineral density of <1% that did not appear to worsen at 12 months of treatment; however, monitoring is recommended.” said Distinguished Professor at the University of California, San Francisco Linda Giudice, M.D., Ph.D., and Chair of the SPIRIT Program Steering Committee.
With endometriosis impacting approximately 190 million women globally, the approval for Myfembree is a large step in fighting this condition safely and painlessly.
Myfembree is available immediately to patients with moderate to severe pain associated with endometriosis as long as they have a prescription from their healthcare provider.