FDA Rejects Treatment for Uterine Fibroids Based on Safety Concerns

Allergan announced that the Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for ulipristal acetate for the treatment of abnormal uterine bleeding in women with uterine fibroids. 

The NDA included data from two Phase 3 clinical trials (VENUS I and VENUS II), all four Phase 3 European Union registration studies, and real-world data of >700,000 women with uterine fibroids across 80 countries. However, the CRL stated that approval of the NDA was not possible in its current form. The Agency requested more information from Allergan, citing safety concerns with Esmya (the trade name for ulipristal acetate in Europe) uncovered in post-marketing reports outside of the US. 

Ulipristal acetate is an investigational selective progesterone receptor modulator (SPRM) that works by acting directly on the progesterone receptors in 3 target tissues: the endometrium, uterine fibroids, and the pituitary gland.

The Company plans to meet with the FDA to discuss their comments and next steps. 

For more information visit Allergan.com.