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Allergan reports positive data from uterine fibroid drug trial
Allergan and its development partner Gedeon Richter have announced new clinical trial data that demonstrates the effectiveness of their new treatment for uterine fibroids.
Positive results have been reported from Venus II, the second of two pivotal phase III clinical trials evaluating the efficacy and safety of the drug ulipristal acetate in women with abnormal bleeding due to uterine fibroids.
A total of 432 US patients were enrolled in the trial, which met all of its co-primary and secondary endpoints, with both ulipristal treatment arms achieving statistically significant benefits compared to placebo.
Based on these findings and the similarly positive results from the earlier Venus I trial, a new drug application filing is planned for submission to the US Food and Drug Administration in the second half of 2017.
If approved, it would become the first and only oral treatment option for women suffering from uterine fibroids in the US.
David Nicholson, chief research and development officer at Allergan, said: "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."
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