Allergan and Gedeon Richter announce positive uterine fibroid drug trial data

Allergan and Gedeon Richter have announced positive findings from a new clinical trial assessing the performance of ulipristal acetate in women with uterine fibroids.

The Venus I study was one of two pivotal phase III clinical trials evaluating the efficacy and safety of the new therapy, with 157 patients enrolled. All co-primary and secondary endpoints were met, with both ulipristal treatment arms achieving statistically significant benefits compared to placebo.

Significantly more patients in the ten mg and five mg ulipristal acetate groups achieved an absence of bleeding compared to placebo, while no treatment-related serious adverse events were observed.

The second of the two clinical trials, Venus II, is expected to be completed this year, with topline results to be reported in the first half of 2017. Allergan will also be filing for regulatory approval of the drug next year.

David Nicholson, executive vice-president and president of global research and development at Allergan, said: "Ulipristal acetate has the potential to offer the first and only non-invasive long-term treatment option for women suffering from uterine fibroids in the US."

This could be an important breakthrough, as uterine fibroids are a leading cause of hysterectomies.