Health Canada has granted a notice of compliance (NOC) to Sumitomo Pharma Canada and Pfizer Canada’s MYFEMBREE (relugolix, estradiol and norethindrone acetate tablets).
The combination therapy, which includes relugolix 40mg, estradiol 1mg and norethindrone acetate 0.5mg, is intended for the management of moderate to severe pain associated with endometriosis in pre-menopausal women.
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In September 2023 it also received approval from Health Canada to manage heavy menstrual bleeding associated with uterine fibroids.
The therapy is recommended for once daily oral dosage.
The approval is based on Phase III studies including LIBERTY 1 and LIBERTY 2 for uterine fibroids, as well as the SPIRIT 1 and SPIRIT 2 clinical trials for endometriosis.
Sumitomo Pharma Canada general manager Lisa Mullett stated: “Health Canada’s approval of MYFEMBREE across the uterine fibroid and endometriosis indications marks a significant milestone in our commitment to women’s health.
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By GlobalData“These are multi-faceted and complex chronic conditions, and we are proud to make new treatment options available to women in Canada.”
With this approval, Pfizer Canada in partnership with Sumitomo Pharma plans to bring MYFEMBREE to Canadians as quickly as possible.
Both companies are assessing the timeline of availability for MYFEMBREE.
Pfizer Canada primary care portfolio lead Andréa Mueller stated: “MYFEMBREE’s approval is a testament to the shared commitment between our two companies to support women’s health.
“We are proud to help women manage their health at all stages of their lives.”
