Allergan and Gedeon Richter’s ulipristal acetate succeeded in one of two pivotal trials, meeting all of its endpoints for efficacy and safety in women with uterine fibroids.
The candidate, at 5- and 10-mg doses, met its primary endpoints of absence of uterine bleeding. No adverse events linked to the treatment were reported.
The second pivotal trial is expected to be finished by the first half of 2017. If that also is successful, the company plans on submitting an NDA in 2017.