Principal Investigator, , Chair of the Departments of Reproductive Biology at Case Western Reserve University and of Obstetrics and Gynecology at University Hospitals MacDonald Women’s Hospital, Cleveland, OH.
Allergan and Gedeon Richter Announce Positive Phase III Results for Ulipristal Acetate 5 and 10 mg in the Treatment of Uterine Fibroids
– First oral therapy to demonstrate efficacy and safety for uterine fibroids in two U.S. pivotal studies –
–VENUS II study reinforces efficacy, safety seen in VENUS I study, meeting all co-primary and secondary endpoints —
— New Drug Application to be filed with U.S. FDA in 2017 —
DUBLIN and BUDAPEST, Hungary , Jan. 17, 2017 /PRNewswire/ — Allergan Plc (NYSE: AGN) and Gedeon Richter Plc . today announced positive results from Venus II, the second of two pivotal phase III clinical trials evaluating the efficacy and safety of ulipristal acetate in women with abnormal bleeding due to uterine fibroids. A new drug application filing for ulipristal acetate is planned for the second half of 2017.
“We are pleased with the favorable results of Venus II supporting the efficacy and safety profile of ulipristal acetate as shown in our Venus I trial,” said David Nicholson , Chief Research and Development Officer, Allergan . ” Allergan is committed to identifying, developing and bringing to market therapies that address unmet need and provide significant value to the healthcare system, including a potential new treatment for symptomatic uterine fibroids. We are confident that the results of our phase III trials for ulipristal acetate may potentially offer the first and only oral treatment option for women suffering from uterine fibroids in the U.S.”
Uterine fibroids, also known as myomas, are the most common benign growths that affect up to 80 percent of women in the United States by the age of 50 and are more prevalent in African-American women. Fibroids are made of muscle cells and other tissues that grow in and around the wall of the uterus, or womb. Uterine fibroids are a significant cause of morbidity. It is estimated that up to 50 percent of women with fibroids will experience symptoms. Women report serious symptoms such as heavy menstrual bleeding, painful menses, pelvic pain, urinary symptoms, bowel dysfunction, pressure within the abdomen and on adjacent pelvic organs, and impact on fertility. In fact, women reported severe to very severe symptoms related to menstrual pain/cramps, heavy or prolonged bleeding, and abdominal pain/cramping. Moreover, heavy uterine bleeding can be associated with iron deficiency anemia, pain, social embarrassment, interference with daily and social activities as well as lost productivity in the work place.
The current mainstay of management is mainly surgical. In fact, uterine fibroids are responsible for over 350,000 hospitalizations and are the leading cause of hysterectomies, accounting for approximately one-third of all hysterectomies annually in the US. The economic burden of uterine fibroids is also large, costing the economy over $34 billion each year.
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland , is a bold, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceuticals, devices and biologic products for patients around the world.
Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women’s health, urology and anti-infective therapeutic categories.