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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-m ....

United States , San Francisco , Albert Liao , Bryan Crowe , Steve Danehy , James Rusnak , Chuck Triano , Linda Giudice , Juan Camilo Arjona Ferreira , University Of California , Program Steering Committee Member , Reproductive Sciences , Global Product Development At Pfizer , Pfizer Inc , Virtual Congress , Myovant Sciences Forward , American Society For Reproductive Medicine , Myovant Sciences , Drug Administration , Exchange Commission , Myovant Sciences Contacts , Myovant Sciences Inc , Sumitomo Dainippon Pharma Co Ltd , Sumitovant Biopharma Ltd , Program In Endometriosis , Numerical Rating Scale ,

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 ....

New York , United States , City Of , United Kingdom , Sumitomo Dainippon Pharma , Sumitovant Biopharma , Mary Stutts Sumitovant Biopharma , Myrtle Potter , Juan Camilo Arjona Ferreira , Myovant Sciences Forward , American Society For Reproductive Medicine , Drug Administration , Myovant Sciences , Dainippon Pharmaceutical Co Ltd , Exchange Commission , Myovant Sciences Inc , European Union , Sumitomo Dainippon Pharma Co Ltd , Virtual Congress , Sumitomo Pharmaceuticals Co Ltd , Sumitovant Biopharma Ltd , Program In Endometriosis , Biopharma Ltd , Myovant Science Phase , New Drug Application , Chief Executive Officer ,

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 Applicat ....

New York , United States , City Of , United Kingdom , Sumitomo Dainippon Pharma , Sumitovant Biopharma , Mary Stutts Sumitovant Biopharma , Myrtle Potter , Juan Camilo Arjona Ferreira , Myovant Sciences Forward , American Society For Reproductive Medicine , Drug Administration , Myovant Sciences , Dainippon Pharmaceutical Co Ltd , Exchange Commission , Myovant Sciences Inc , European Union , Sumitomo Dainippon Pharma Co Ltd , Virtual Congress , Sumitomo Pharmaceuticals Co Ltd , Sumitovant Biopharma Ltd , Program In Endometriosis , Biopharma Ltd , Myovant Science Phase , New Drug Application , Chief Executive Officer ,

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

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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 ....

United States , San Francisco , James Rusnak , Linda Giudice , Juan Camilo Arjona Ferreira , University Of California , Program Steering Committee Member , American Society For Reproductive Medicine , Drug Administration , Myovant Sciences , Reproductive Sciences , Global Product Development At Pfizer , Pfizer Inc , Myovant Sciences Inc , Virtual Congress , Program In Endometriosis , Numerical Rating Scale , New Drug Application , Distinguished Professor , Steering Committee , Chief Medical Officer , Senior Vice President , Chief Development Officer , Internal Medicine , Global Product Development , American Society ,

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 ....

United States , San Francisco , Albert Liao , Bryan Crowe , Steve Danehy , James Rusnak , Chuck Triano , Linda Giudice , Juan Camilo Arjona Ferreira , University Of California , Program Steering Committee Member , Reproductive Sciences , Global Product Development At Pfizer , Pfizer Inc , Virtual Congress , Myovant Sciences Forward , American Society For Reproductive Medicine , Drug Administration , Myovant Sciences , Exchange Commission , Myovant Sciences Contacts , Myovant Sciences Inc , Sumitomo Dainippon Pharma Co Ltd , Sumitovant Biopharma Ltd , Program In Endometriosis , Numerical Rating Scale ,