The FDA has decided not to approve the Uterine Fibroid drug, Esyma

For Immediate Release
Contact: Cynthia Pearson, cpearson@nwhn.org
Telephone: (202) 682-2640, x222

 

The following statement can be attributed to Cynthia A. Pearson, Executive Director of the National Women’s Health Network.

 

Washington, D.C. — Esmya, a drug intended to treat uterine fibroids, was turned down by the U.S. Food and Drug Administration in a decision announced by Allergan, the U.S. sponsor. The NWHN applauds the FDA for this decision.

Women count on the FDA to make sure products are safe and there were very important safety concerns about using this drug. At least four cases of severe liver damage have been reported in European women, where the drug has been used for several years to control symptoms of fibroids.

Uterine fibroids are common, and can be problematic, interfering with work, quality of life and, in some cases, fertility. There are very few non-surgical options available to patients. As such, there has been a recent surge in development of new uterine fibroid medications designed to help patients manage and treat the condition.

NWHN has advocated for better treatments for fibroids for a long time, including drugs.  Hopefully drugs in the pipeline will be found to be both safe and effective.

We applaud the FDA for following the science.

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