Ulipristal Acetate’s New Drug Application Accepted By The FDA

Allergan plc Ordinary Shares (NYSE:AGN) has announced that the Food and Drug Administration has accepted its New Drug Application to market its investigation treatment known as ulipristal acetate. According to Allergan, the Food and Drug Administration could decide on ulipristal acetate next year in the first six months. The drug is used to treat abnormal bleeding in females suffering from uterine fibroids.

“Uterine fibroids have a serious impact on public health, and I am hopeful ulipristal acetate will offer millions of women a new, nonsurgical treatment option that will help them manage their uterine fibroids,” Millie Behera, Bloom Reproductive Institute’s reproductive endocrinology and fertility medical director, said.

Uterine fibroids

In Europe ulipristal acetate is marketed as Esmya by Gedeon Richter while in Canada its trade name is Fibristal and is marketed by Allergan. Both Fibristal and ulipristal acetate have received approval for the treatment of uterine fibroids among adult women who have reached reproductive age and who are also eligible for surgery.

The safety and efficacy of the treatment was demonstrated in phase III clinical trials numbering four which were conducted on patients suffering from uterine fibroids on the European continent.

Clinical trials

In North America over 500 adult females took part in two phase III clinical trials – Venus 1 and Venus 2. Robust results were obtained from the study showing that ulipristal acetate was safe and effective with regards to treating uterine fibroids. In over 70 countries ulipristal acetate has been used to treat thousands of adult women suffering from this condition.

Per Allergan, progesterone is instrumental in the growth and development of uterine fibroids. Ulipristal acetate acts by blocking progesterone’s effect on the uterus lining as well as on the pituitary gland. Consequently the fibroids shrink, the pain subsides and the heavy menstrual bleeding stops.


Read the full article at the Original Source..

Back to Top