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Find Clinical Drug Pipeline Developments & Deals by Sumitovant Biopharma
Sumitovant and Myovant will strengthen Myovant's two products, Orgovyx® (relugolix) and Myfembree® capabilities and help continue to deliver innovative therapies addressing unmet patient needs in prostate cancer and women's health.
The collaboration combines Neochromosome’s neoYeastTM platform with Sumitovant’s DrugOMETM computational ecosystem to identify novel proteins that would benefit from non-canonical amino acid chemistries that are not found in nature.
Sumitovant and Myovant will strengthen Myovant's two products, Orgovyx® (relugolix) and Myfembree® capabilities and help continue to deliver innovative therapies addressing unmet patient needs in prostate cancer and women's health.
MYFEMBREE (relugolix, estradiol, and norethindrone acetate) is a once-daily oral treatment approved by the U.S. Food and Drug Administration for the management of moderate to severe pain associated with endometriosis, with a treatment duration of up to 24 months.
ORGOVYX® (relugolix), is the first and only oral androgen deprivation therapy for an oral medication used to treat adult patients with advanced hormone-sensitive prostate cancer.
MYFEMBREE (relugolix, estradiol, and norethindrone acetate) is first and only once-daily oral treatment for heavy menstrual bleeding associated with uterine fibroids in premenopausal women approved by USFDA with a treatment duration of up to 24 months.
ORGOVYX® (relugolix), which is a gonadotropin-releasing hormone (GnRH) antagonist that is approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with advanced prostate cancer.
The sNDA proposes updates to MYFEMBREE (Relugolix) based on safety and efficacy data from the Phase 3 LIBERTY randomized withdrawal study of MYFEMBREE in premenopausal women with heavy menstrual bleeding associated with uterine fibroids for up to two years.
Myovant will continue to lead the global development of Orgovyx (relugolix) and provide product supply to Accord. Accord will be responsible for certain local clinical development, commercialization for its territories, and has the option to manufacture relugolix in future.
MYFEMBREE (relugolix, estradiol, and norethindrone acetate) is first once-daily oral treatment for heavy menstrual bleeding associated with uterine fibroids in premenopausal women approved by U.S. FDA, with a treatment duration of up to 24 months.
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