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Bayer moves vilaprisan into phase III trials for uterine fibroids

ASTEROID study will investigate safety and efficacy of the novel drug

Bayer

Bayer is beginning late-stage trials of vilaprisan, its novel oral, selective progesterone receptor modulator (SPRM) treatment for women with uterine fibroids.

The three-year, phase III ASTEROID study will investigate the efficacy and safety of 2mg of vilaprisan in patients with symptomatic uterine fibroids, and aims to recruit more than 3,600 patients in 900 centres across 40 countries.

Uterine fibroids are the most common benign gynecological tumors, with approximately 5-10% of women requiring treatment for the disease.

Efficacy measures will be assessed within the trial programme including the effect on heavy menstrual bleeding, reduction in fibroid size and improvement in quality of life.

Dr Joerg Moeller, member of the executive committee of Bayer AG’s pharmaceutical division and head of development, said the work would build on a phase II study of vilaprisan that had delivered “promising results”.

“It is our ambitious goal that our research efforts in this field result in a medical therapy that control symptoms and thereby significantly improves the quality of life for women with uterine fibroids,” he added.

Meanwhile, Allergan and Gedeon Richter plan to file their uterine fibroid drug ulipristal acetate in the US by the end of the year and Astellas is also busy in this area, have acquired Ogeda and its phase IIa candidate Fezolinetant.

Article by
Gemma Jones

7th July 2017

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