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 investingnews.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from investingnews.com Daily Mail and Mail on Sunday newspapers.
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Uterine fibroids are a common cause of heavy menstrual bleeding and pain in women of reproductive age, especially among women of color. An estimated $34 billion in healthcare costs are associated with uterine fibroids in the United States alone each year, yet there are few treatment options other than surgery.
Now a University of Chicago Medicine researcher working with an international team of scientists has developed a daily oral combination therapy that is reliable, safe and effective for long-term treatment of uterine fibroids. This discovery is an important new tool that will be an important addition to the field, said Ayman Al-Hendy, MD, PhD, a professor of obstetrics and gynecology and lead author of the study, which was published February 17, 2021 in the
For the first time, we have an oral treatment that can effectively and safely improve the symptoms of uterine fibroids, particularly heavy menstrual bleeding, Al-Hendy said in an interview, adding that relugolix may be a viable, longer-term alternative to the current treatments available for fibroids patients.
One other oral therapy, Oriahnn (elagolix, estradiol, and norethindrone acetate), is FDA approved for fibroid-related bleeding. However, the drug can only be taken for up to 24 months due to the risk of bone loss. The goal of this program from the beginning was to develop an effective and long-term treatment as a viable alternative to hysterectomy, Al-Hendy stated. Any patient with uterine fibroids would be a good candidate for this non-surgical treatment.
ObsEva SA: ObsEva Provides Business Outlook for 2021
GENEVA, Switzerland and BOSTON, MA (February 10, 2021) - ObsEva SA (NASDAQ: OBSV; SIX: OBSN), a biopharmaceutical company developing and commercializing novel therapies to improve women s reproductive health, today provided a corporate update, including its roadmap for advancing its clinical programs in 2021. We made significant progress across all aspects of the company in 2020, most significantly preparing Yselty for uterine fibroids for regulatory approval with a filed and validated European marketing authorization application and an upcoming planned new drug application in the US, said Brian O Callaghan, CEO of ObsEva. Meanwhile our other pipeline programs have continued to advance through development as evidenced by the recent exciting topline results from the PROLONG Phase 2a proof-of concept study of ebopiprant which, to our knowledge, is the only candidate drug in active development that has the potential to delay deli
for Uterine Fibroids
ObsEva is developing Yselty®, an oral GnRH receptor antagonist with the potential to treat more women thanks to its potential best-in-class efficacy, a favorable tolerability profile and unique, flexible dosing options for the treatment of uterine fibroids. Following the European Medicine Agency’s (EMA) recent validation of the marketing authorization application (MAA), a major milestone toward making Yselty® available in the E.U., the Company will continue to work closely with the EMA to achieve marketing approval, projected in Q4:2021.
The second key objective for 2021 will be to submit a U.S. New Drug Application (NDA), projected in Q2:2021, that will include the Week 76 post-treatment follow-up results from the Phase 3 PRIMROSE 1 (US only; n=574) and PRIMROSE 2 (Europe and US; n=535) clinical studies. In both studies, patients with heavy menstrual bleeding (HMB) associated with uterine fibroids were administered Yselty doses of 100 mg or 200 mg, with a