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Myovant Sciences and Pfizer Announce Positive Data from Phase 3 LIBERTY Randomized Withdrawal Study of Once-Daily Relugolix Combination Therapy in Women with Uterine Fibroids

Myovant Sciences and Pfizer Announce Positive Data from Phase 3 LIBERTY Randomized Withdrawal Study of Once-Daily Relugolix Combination Therapy in Women with Uterine Fibroids
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Myovant Sciences and Pfizer Announce Positive Data from Phase 3 LIBERTY Randomized Withdrawal Study of Once-Daily Relugolix Combination Therapy in Women with Uterine Fibroids

Myovant Sciences and Pfizer Announce Positive Data from Phase 3 LIBERTY Randomized Withdrawal Study of Once-Daily Relugolix Combination Therapy in Women with Uterine Fibroids
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Myovant Sciences and Pfizer Announce Publication in New England Journal of Medicine of Phase 3 LIBERTY Studies of Once-Daily

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Myovant Sciences and Pfizer Announce Publication in New England Journal of Medicine of Phase 3 LIBERTY Studies of Once-Daily
(GLOBE NEWSWIRE) — Myovant Sciences (NYSE: MYOV) and Pfizer Inc. (NYSE: PFE) today announced publication in the New England Journal of Medicine of the Phase 3 LIBERTY 1 and LIBERTY 2 studies of investigational once-daily relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in women with uterine fibroids. As previously reported, both studies achieved the primary endpoint of response rates in menstrual blood loss in addition to six of the seven key secondary endpoints, while maintaining bone mineral density comparable to placebo as part of a well-tolerated safety profile over 24 weeks.

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Sumitovant Biopharma Announces Publication in the New England Journal of Medicine of Myovant Sciences Phase 3 LIBERTY Studies of Once-Daily Relugolix Combination Therapy in Women with Uterine Fibroids

Sumitovant Biopharma Announces Publication in the New England Journal of Medicine of Myovant Sciences Phase 3 LIBERTY Studies of Once-Daily Relugolix Combination Therapy in Women with Uterine Fibroids
•LIBERTY 1 and LIBERTY 2 achieved 73.4% and 71.2% response rates in menstrual blood loss, with an average reduction of 84.3% from baseline •Achieved six of seven key secondary endpoints including reduction of pain •Bone mineral density maintained at levels comparable to placebo •Data were included in U.S. New Drug Application for relugolix combination tablet for uterine fibroids
February 17, 2021 20:02 ET
| Source:
Sumitovant Biopharma
Sumitovant Biopharma
New York, New York, UNITED STATES
New York, London, Feb. 17, 2021 (GLOBE NEWSWIRE) -- Sumitovant Biopharma Ltd., a majority shareholder of Myovant Sciences (NYSE: MYOV), announced today that the

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Myovant Sciences and Pfizer Announce Publication in the New England Journal of Medicine of Phase 3 LIBERTY Studies of Once-Daily Relugolix Combination Therapy in Women with Uterine Fibroids

Myovant Sciences and Pfizer Announce Publication in the New England Journal of Medicine of Phase 3 LIBERTY Studies of Once-Daily Relugolix Combination Therapy in Women with Uterine Fibroids
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Myovant Sciences and Pfizer Announce Positive One-Year Data from Phase 3 SPIRIT Extension Study of Once-Daily Relugolix Combination Therapy in Women with Endometriosis

Published: Jan 26, 2021
84.8% and 73.3% of women reported clinically meaningful reductions in dysmenorrhea (menstrual pain) and non-menstrual pelvic pain at one year
82.8% average reduction from baseline
on the Numerical Rating Scale for dysmenorrhea from 7.4 (severe pain) to 1.3 (mild pain)
over one year
Bone mineral density loss was minimal at Week 24 and remained stable through one year
Data to be included in New Drug Application submission to U.S. Food and Drug Administration anticipated in first half of 2021
BASEL, Switzerland and NEW YORK, Jan. 26, 2021 (GLOBE NEWSWIRE) -- Myovant Sciences (NYSE: MYOV) and Pfizer Inc.. (NYSE: PFE) today announced that the Phase 3 SPIRIT long-term extension study of the investigational once-daily relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in women with endometriosis reported clinically meaningful reductions in dysmenorrhea (menstrual pain) and non-menstrual pelvic pain over one year (52 weeks) with minimal and stable bone mineral density loss. The data are consistent with the efficacy and safety profile observed through 24 weeks in the Phase 3 SPIRIT 1 and SPIRIT 2 studies. These results will be included in the New Drug Application to the U.S. Food and Drug Administration for relugolix combination tablet for the treatment of women with endometriosis, anticipated to be submitted in the first half of 2021.

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UPDATE: Sumitovant Biopharma Announces Myovant Sciences Positive One-Year Data from Phase 3 SPIRIT Extension Study of Once-Daily Relugolix Combination Therapy in Women with Endometriosis

•84.8% and 73.3% of women reported clinically meaningful reductions in dysmenorrhea (menstrual pain) and non-menstrual pelvic pain at one year •Data to be included in New Drug Application submission to U.S. Food and Drug Administration anticipated in first half of 2021

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UPDATE: Sumitovant Biopharma Announces Myovant Sciences Positive One-Year Data from Phase 3 ...

Press release content from Globe Newswire. The AP news staff was not involved in its creation.
UPDATE: Sumitovant Biopharma Announces Myovant Sciences Positive One-Year Data from Phase 3 ...
Sumitovant BiopharmaJanuary 26, 2021 GMT
NEW YORK, LONDON,, Jan. 26, 2021 (GLOBE NEWSWIRE) -- Sumitovant Biopharma Ltd., a majority shareholder of Myovant Sciences (NYSE: MYOV), announced today that Myovant Sciences’ Phase 3 SPIRIT long-term extension study of the investigational once-daily relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in women with endometriosis reported clinically meaningful reductions in dysmenorrhea (menstrual pain) and non-menstrual pelvic pain over one year (52 weeks) with minimal and stable bone mineral density loss. The dat a are consistent with the efficacy and safety profile observed through 24 weeks in the Phase 3 SPIRIT 1 and SPIRIT 2 studies. These results will be included in the New Drug Application to the U.S. Food and Drug Administration for relugolix combination tablet for the treatment of women with endometriosis, anticipated to be submitted in the first half of 2021. Myovant is a healthcare company focused on redefining care for women and for men, and one of five healthcare companies in the Sumitovant family of companies.

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Myovant Sciences and Pfizer Announce Positive One-Year Data from Phase 3 SPIRIT Extension Study of Once-Daily Relugolix Combination

Date Time
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Myovant Sciences and Pfizer Announce Positive One-Year Data from Phase 3 SPIRIT Extension Study of Once-Daily Relugolix Combination
84.8% and 73.3% of women reported clinically meaningful reductions in dysmenorrhea (menstrual pain) and non-menstrual pelvic pain at one year
82.8% average reduction from baseline on the Numerical Rating Scale for dysmenorrhea from 7.4 (severe pain) to 1.3 (mild pain) over one year
Bone mineral density loss was minimal at Week 24 and remained stable through one year
Data to be included in New Drug Application submission to U.S. Food and Drug Administration anticipated in first half of 2021
BASEL, Switzerland and NEW YORK, January 26, 2021 – Myovant Sciences (NYSE: MYOV) and Pfizer Inc. (NYSE: PFE) today announced that the Phase 3 SPIRIT long-term extension study of the investigational once-daily relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in women with endometriosis reported clinically meaningful reductions in dysmenorrhea (menstrual pain) and non-menstrual pelvic pain over one year (52 weeks) with minimal and stable bone mineral density loss. The data are consistent with the efficacy and safety profile observed through 24 weeks in the Phase 3 SPIRIT 1 and SPIRIT 2 studies. These results will be included in the New Drug Application to the U.S. Food and Drug Administration for relugolix combination tablet for the treatment of women with endometriosis, anticipated to be submitted in the first half of 2021.

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Myovant Sciences and Pfizer Announce Positive One-Year Data from Phase 3 SPIRIT Extension Study ...

Press release content from Globe Newswire. The AP news staff was not involved in its creation.
Myovant Sciences and Pfizer Announce Positive One-Year Data from Phase 3 SPIRIT Extension Study ...
Myovant Sciences, Inc.January 26, 2021 GMT
84.8% and 73.3% of women reported clinically meaningful reductions in dysmenorrhea (menstrual pain) and non-menstrual pelvic pain at one year
82.8% average reduction from baseline
on the Numerical Rating Scale for dysmenorrhea from 7.4 (severe pain) to 1.3 (mild pain)
over one year
Bone mineral density loss was minimal at Week 24 and remained stable through one year
Data to be included in New Drug Application submission to U.S. Food and Drug Administration anticipated in first half of 2021

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