Sumitomo Pharma and Pfizer in Canada Receive Health Canada Approval for MYFEMBREE®

MISSISSAUGA, ON and KIRKLAND, QC, Oct. 19, 2023 /PRNewswire/ -- Sumitomo Pharma Canada, Inc. and Pfizer Canada today announced that Health Canada has granted a Notice of Compliance (NOC) for MYFEMBREE (Relugolix, estradiol and norethindrone acetate tablets) for the management of moderate to severe pain associated with endometriosis in pre-menopausal women on October 17, 2023. On September 22, 2023, Health Canada also approved MYFEMBREE for the management of heavy menstrual bleeding associated with uterine fibroids in pre-menopausal women. This combination therapy oral treatment is taken once daily and provides a new option for women to manage their symptoms related to endometriosis and uterine fibroids.

"Health Canada's approval of MYFEMBREE across the uterine fibroid and endometriosis indications marks a significant milestone in our commitment to women's health," said Lisa Mullett, General Manager, Sumitomo Pharma Canada, Inc. "These are multi-faceted and complex chronic conditions, and we are proud to make new treatment options available to women in Canada."

"MYFEMBREE's approval is a testament to the shared commitment between our two companies to support women's health," added Andréa Mueller, Primary Care Portfolio Lead at Pfizer Canada. "We are proud to help women manage their health at all stages of their lives." 

This approval is based on several comprehensive Phase 3 studies, including the LIBERTY 1 and LIBERTY 2 trials for uterine fibroids and the SPIRIT 1 and SPIRIT 2 trials for endometriosis.

"Uterine fibroids and endometriosis are very common conditions affecting millions of Canadians. Endometriosis, in particular, can be a very challenging and complex condition to treat, often resulting in years of delay to diagnosis, said Dr. Sony Sukhbir Singh, Professor and Chair of the Department of Obstetrics and Gynecology, at the University of Ottawa. "These conditions can cause debilitating symptoms such as pain and bleeding, impacting daily life and overall well-being for many girls, women and gender diverse individuals." 

Following this approval Pfizer Canada will lead commercialization efforts of MYFEMBREE in the uterine fibroid and endometriosis indications. In partnership with Sumitomo Pharma in Canada, Pfizer Canada is currently assessing the timeline of availability for MYFEMBREE and are committed to bringing supply of this medicine to Canadians as quickly as possible.

About Uterine Fibroids

Uterine fibroids are the most common benign tumors in women of reproductive age.¹ Uterine fibroids may be underdiagnosed due to several factors. Roughly 50 to 80% of women may have asymptomatic fibroids, meaning they don't experience noticeable symptoms. Additionally, some women with fibroid-related symptoms, such as heavy menstrual bleeding and pain, might not seek medical attention because they consider these issues to be a normal part of their menstrual cycles. Furthermore, healthcare providers may sometimes dismiss these symptoms as normal, contributing to the underestimation of uterine fibroid prevalence in Canadian women.