PharmaShots Interview: Myovant's Dave Marek Shares Insights on the US FDA's Approval of Myfembree in Uterine Fibroids

In an interview with PharmaShots, Dave Marek. CEO of Myovant shares insights on the US FDA's approval of Myfembree (relugolix 40mg, estradiol 1mg, and norethindrone acetate 0.5mg) in Uterine Fibroids.

Shots:

The US FDA has approved Myovant & Pfizer's Myfembree (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) as the first once-daily treatment for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women, with a treatment duration of ~24mos.
The approval is supported by the efficacy and safety data from the P-III LIBERTY 1 and LIBERTY 2 studies of Myfembree in women with uterine fibroids
The US FDA approval of Myfembree represents a significant milestone in expanding treatment options for uterine fibroids, a chronic and debilitating disease for many women in the US

Tuba: Discuss the key points of the FDA approval of Myfembree as the first once-daily treatment for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women?

Dave: Myfembree (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) is the first once-daily treatment for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women, with a treatment duration of up to 24 months. The approval is supported by the efficacy and safety data from the Phase 3 LIBERTY 1 and LIBERTY 2 studies of Myfembree in women with uterine fibroids. As a new, once-daily oral treatment, Myfembree's approval is an important step forward in a disease area that has historically relied heavily on invasive procedures such as myomectomies and hysterectomies.

Tuba: Discuss the indications, usage, and safety information about Myfembree.

Dave: Myfembree is approved by the U.S. Food and Drug Administration for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women. The label for Myfembree is representative of its strong benefit-risk profile, which allows Myovant and Pfizer to serve women with uterine fibroids by providing a non-invasive option for women looking to achieve clinically meaningful symptom relief with a once-daily oral treatment. The label also represents Myfembree's tolerability among patients, especially with respect to hot flush and bone mineral density, which are key considerations for patients and healthcare professionals.

Tuba: What does the approval of Myfembree represent? Does this shared commitment find its way to support women living with uterine fibroids?

Dave: Myovant and Pfizer believe Myfembree has the potential to improve the standard of care for women with uterine fibroids by providing a non-invasive option for women looking to achieve clinically meaningful symptom relief with a once-daily oral treatment. Current standard treatment options for heavy menstrual bleeding due to uterine fibroids include medical therapies and surgery, but women and healthcare professionals want choices when it comes to safely and effectively addressing symptoms. Having different treatment options, including those beyond surgery, is important for improving care for women with uterine fibroids.

Tuba: This is an important step forward as we seek to redefine care for women and men, not only through new medicines but through continued collaboration with the community. Shed some light on this statement?

Dave: At Myovant, we not only focus on therapeutic areas that need better clinical options, but also where we can make a real impact through improving patient education, closing health equity gaps, and stamping out social stigma. We seek to redefine care by removing these barriers, which can prevent people from receiving the care they need.

For example, through cross-sector partnerships, Myovant is turning our words into action. Female Forward Together is a coalition committed to advancing research, education, and action for women's health. It brings together expertise in healthcare, digital health, and advocacy to elevate the conversation around women's health and break the stigma often associated with it. Myovant has also provided its Forward for Health Equity grants for up to $50,000 to two nonprofit organizations focused on improving healthcare access, with an initial focus on reducing racial disparities in uterine fibroids in the U.S.

Tuba: With the limited options of treatment of uterine fibroids available in the US, will Myfembree be a boom medicine for women suffering from this disease? As Myfembree plays a significant milestone in expanding treatment options for uterine fibroids, a chronic and debilitating disease for many women in the U.S. Highlight the key features of this medicine?

Dave: Given that approximately 19 million women in the U.S. have uterine fibroids and an estimated five million women in the U.S. suffer from symptoms of uterine fibroids, Myfembree has the potential to improve the standard of care for these women as the only therapy that can do three things: offer significant efficacy, be well-tolerated with a consistent safety profile, and have the convenience of one tablet once a day.

Tuba: How much will Pfizer contribute towards this new treatment option, which provides the convenience of an oral-once daily tablet?

Dave: Myovant and Pfizer will jointly commercialize Myfembree in women's health in the U.S. This includes building commercial capabilities around medical affairs, marketing, market access, and commercial operations. Pfizer is an ideal partner for Myovant with its deep heritage and leadership in women's health combined with its experienced women's health field force.

Main Image Source: Premier Health

About Dave Marek:

Dave Marek is the Chief Executive Officer at Myovant Sciences. Mr. Marek previously served as Chief Commercial Officer of Axsome Therapeutics. Before joining Axsome, Mr. Marek served as Vice President and General Manager of Amgen's Neuroscience business unit where he led the US commercialization strategy and launch of Aimovig (erenumab-aooe) for migraine prevention.