Allergan/Gedeon uterine fibroids therapy headed for NDA

Allergan plc (NYSE:AGN) and Gedeon Richter Ltd. (Budapest:RICHTER) said ulipristal acetate (PGL4001) met all co-primary and secondary endpoints in VENUS II, the second of two Phase III trials evaluating the compound to treat uterine fibroids. The companies expect to submit an NDA to FDA in 2H17 for the selective progesterone receptor modulator (SPRM).

Compared to placebo, the study's 5 mg and 10 mg doses of ulipristal significantly improved the percentage of patients with absence of uterine bleeding (42% for 5 mg and 54.8% for 10 mg ulipristal vs. zero for placebo), meeting a co-primary endpoint. Ulipristal also met a second co-primary endpoint, time to absence of uterine bleeding during the study's first 12-week treatment course...