Sumitomo Pharma Announces Availability of ORGOVYX® (relugolix) in Canada
Sumitomo Pharma Canada announced that Health Canada has approved ORGOVYX (relugolix), an oral gonadotropin-releasing hormone (GnRH) receptor antagonist, for the treatment of men with advanced prostate cancer. The approval is based on efficacy and safety data from the Phase 3 HERO study of ORGOVYX in men with advanced prostate cancer. ORGOVYX is expected to be available for prescription in Canada in Q1 2024.
MISSISSAUGA, Ontario, Oct. 23, 2023 /PRNewswire/ -- Sumitomo Pharma Canada, Inc., announced today that Health Canada has approved ORGOVYX® (relugolix), an oral gonadotropin-releasing hormone (GnRH) receptor antagonist, for the treatment of men with advanced prostate cancer. The approval is based on efficacy and safety data from the Phase 3 HERO study of ORGOVYX in men with advanced prostate cancer. ORGOVYX is expected to be available for prescription in Canada in Q1 2024.
Gedeon`s Ryeqo (Relugolix) Receives Approval in Europe
ATLANTA -- October 17, 2022 -- Combination therapy with relugolix, estradiol, and norethindrone acetate was effective for heavy menstrual bleeding associated with uterine fibroids in presumed perimenopausal women, according to a subanalysis of the LIBERTY 1 and 2 trials, researchers reported at the 2022 Annual Meeting of the North American Menopause Society (NAMS).
After a bump in the road back in April, Myovant and Pfizer have won a label expansion covering Myfembree's use in endometriosis.
BASEL, Switzerland and NEW YORK, Aug. 05, 2022 (GLOBE NEWSWIRE) -- Myovant Sciences (NYSE: MYOV) and Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved MYFEMBREE® (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) as a one-pill, once-a-day therapy for the management of moderate to severe pain associated with endometriosis in pre-menopausal women, with a treatment duration of up to 24 months. The approval is supported by one-year efficacy and safety data, including 24-week data from the Phase 3 SPIRIT 1 and SPIRIT 2 trials, which were published in The Lancet, and the first 28 weeks of an open-label extension study for eligible women who completed either SPIRIT 1 or SPIRIT 2. MYFEMBREE also is approved for heavy menstrual bleeding associated with uterine fibroids in pre-menopausal women. Myovant and Pfizer will continue to jointly commercialize MYFEMBREE in the U.S. and product is available immediately.
Earlier this year, the FDA sent letters to Pfizer and Myovant flagging problems that meant conversations about labeling or postmarketing requirements couldn't proceed for Myfembree in endometriosis pain. Since then, Myovant said in its quarterly earnings press release, the FDA provided it with labeling comments for the gonadotropin-releasing hormone (GnRH) antagonist.
Myovant Sciences Generic Orgovyx (Relugolix) Receives Approval in Europe
LOUISVILLE, Ky.--(BUSINESS WIRE)--Onco360®, the nation’s leading independent Specialty Pharmacy, has been selected by Myovant Sciences to be a specialty pharmacy partner for 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.