Health Canada has granted regulatory approval to Pfizer (NYSE: PFE) and Sumitomo Pharma (TYO: 4506) for their women’s health product Myfembree (relugolix + estradiol + norethindrone acetate). The approval is for the management of moderate-to-severe pain associated with endometriosis in pre-menopausal women, supported by late-stage data from multiple trials.
Previous Approval and New Indication
Myfembree, a once-daily pill, was previously approved in Canada for managing heavy menstrual bleeding associated with uterine fibroids in pre-menopausal women. With this new approval, the drug now has two indications in the country, both of which are also approved in the US market.
Commercialization Responsibility
Pfizer will be responsible for the commercialization of Myfembree in Canada, further expanding the availability of treatment options for women’s health conditions.-Fineline Info & Tech
