Myovant Sciences Announces European Commission Approval for RYEQO® for the Treatment of Women With Uterine Fibroids
- RYEQO is the first and only once-daily long-term treatment for uterine fibroids in
- Indication has no limitation for duration of use, as supported by safety and efficacy data from the Phase 3 LIBERTY program
- Gedeon Richter to commercialize RYEQO, starting in the second half of 2021;
Myovantto receive a regulatory milestone payment and is eligible to receive tiered royalties on net sales as well as sales milestone payments
- Marketing authorization application for RYEQO for endometriosis-associated pain on track for submission this calendar year
“Data from the Phase 3 LIBERTY program, which supported the approval of RYEQO, showed that RYEQO improved symptoms most relevant to women living with uterine fibroids, namely heavy menstrual bleeding and pain, while maintaining a well-tolerated safety profile,” said Roberta Venturella, M.D., Ph.D., Associate Professor, Magna Græcia
“Today’s approval of RYEQO, the first and only once-daily long-term treatment for women with uterine fibroids in
The approval is based on safety and efficacy data from the Phase 3 LIBERTY program, which consisted of two replicate, 24-week, multinational clinical studies (LIBERTY 1 and LIBERTY 2), a one-year extension study, and supportive bone mineral density data from a randomized withdrawal study. Results from the LIBERTY 1 and LIBERTY 2 studies were published in the
About Uterine Fibroids
Uterine fibroids are noncancerous tumors that develop in or on the muscular walls of the uterus and are among the most common reproductive tract tumors in women. In addition to an individual's genetic predisposition, estrogens are well known to play an important role in the regulation of fibroid growth.
Although uterine fibroids are benign tumors, they can cause debilitating symptoms such as heavy menstrual bleeding (frequently resulting in anemia and fatigue), pain (including painful periods, abdominal pain, painful intercourse, backache), increased abdominal girth and bloating, urinary frequency or retention, constipation, pregnancy loss, and, in some cases, infertility. These symptoms can also lead to loss of productivity at work, limitations in normal activities of daily living, and social embarrassment.
RYEQO (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) is approved for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age. RYEQO contains relugolix, which reduces the amount of estrogen (and other hormones) produced by ovaries, estradiol (an estrogen), which may reduce the risk of bone loss, and norethindrone acetate (a progestin), which is necessary when women with a uterus (womb) take estrogen.
About Myovant Sciences
Myovant Sciences aspires to redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy. Founded in 2016, we have two FDA-approved products. ORGOVYX™ (relugolix) was approved by the
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In this press release, forward-looking statements include, but are not limited to, all statements reflecting Myovant Sciences’ expectations, including: statements regarding Myovant’s aspiration to redefine care for women and for men; the expectations of commercialization of RYEQO for uterine fibroids in Europe by Gedeon Richter; the submission of the marketing authorization application for RYEQO for endometriosis-associated pain; Myovant’s expectations regarding the potential benefits of RYEQO and it serving as a long-term treatment option for managing heavy menstrual bleeding and pain associated with uterine fibroids; and Myovant’s expectations regarding
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Source: Myovant Sciences, Inc.