Endometrial fibroid synoda innovation therapy reaches phase 3 clinical end, plans to submit new drug application by the end of the year
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Last Update: 2020-06-17
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Source: Internet
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Author: User
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Uterine fibroids are non-malignant tumors that grow in the lining of the uterus or on the walls of the uterus, and are one of the most common reproductive tumors in womenIn addition to genetic factors, estrogen levels are an important factor in regulating fibroid growthUterine fibroids can cause incontining symptoms, including abnormal uterine bleeding, severe menstrual bleeding, anemia, abdominal pain, etc., and may lead to infertilityThese symptoms can lead to reduced patient productivity and limited daily activityAccording to statistics, 5 million women in the United States suffer from uterine fibroid symptoms, of which about 3 million are not adequately controlledRelugolix combination therapy contains relugolix (40 mg), estradiol (1.0 mg), and acetate ketone (0.5 mg) per tabletAs a gonadotropin-releasing hormone (GnRH) receptor antagonist, relugolix reduces estrogen levels produced by the ovaries, thereby alleviating a range of symptoms of uterine fibroidsrelugolix's molecular structure (Photo: Meodipt (Public Domain)The latest trial results of LIBERTY2 showed that 71.2% of patients treated with relugolix combination therapy met the preset clinical endpoint of the pre-set mitigation criteria, with a value of 14.7% (p 0.0001) in the placebo groupThe mitigation criterion is less than 80 ml of menstrual bleeding, or by more than 50% in the final 35 days of treatment compared to baselinesThe relugolix combination therapy group had an 84.3 percent reduction in average menstrual bleeding compared to the baseline, and significantly increased the proportion of patients with moderate to severe pain relief to painless or mild painThe therapy also showed good safety and had no significant effect on bone density in patients" Myovant has demonstrated the unique efficacy of relugolix combination therapy in two large Phase 3 clinical trials and a separate bioequivalence trialThe treatment not only significantly relieves the patient's symptoms, but also has good tolerance and safety," said DrLynn Seely, President and CEO of MyovantReferences:Myovant Sciences Announces Positive Results from Phase Phase 2 3 Study Evaluating Once-Daily Relugolix Group Therapy in Women With QuithIods and Positive Results from Bioequival Retrieved July 23, 2019, from the of the rapid delivery of the post, reduced the amount of bleeding by 80%, and the innovative therapy for uterine fibroids reached the clinical end of Stage 3 Retrieved July 23, 2019, from original title: Express, uterine fibroid synth therapy reaches phase 3 clinical end, submits new drug application by the end of the year
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