FDA Rejects Allergan's Uterine Fibroid Treatment Following EMA Concerns Over Liver Damage


The U.S. Food and Drug Administration (FDA) rejected Allergan’s New Drug Application for ulipristal acetate.

Allergan announced Tuesday that the treatment for abnormal bleeding in women with uterine fibroids was issued a Complete Response Letter by the regulatory agency. In a brief statement, Allergan said the FDA cited safety concerns regarding post-marketing reports outside of the United States. While the company did not offer much in the way of information, those post-marketing reports are likely related to the European Medicines Agency (EMA) investigation into questions over whether or not treatment with Esmya, the name UA is marketed under in Europe, led to liver damage in some patients. In Europe, Esmya is approved for the pre-operative and intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.

The EMA launched its investigation in March and concluded it in May. The committee investigating ruled that the medication may have contributed to some cases of “serious liver injury” and recommended limited treatment with the medicine. At the end of May, the EMA issued new measures to minimize the risk of liver injury. The measures the EMA instituted include contraindication in women with known liver problems, liver tests before, during and after treatment with Esmya and a notice for patients about the risks of liver damage.

Allergan said the FDA has asked for additional information about the medication and plans to meet with the FDA to discuss the concerns and the next steps for the drug. How long that may take is unknown, as the Ireland-based company did not provide details contained within the CRL.

David Nicholson, Allergan’s head of research and Development, said the company continues to believe there is a need for “novel treatment options for women who are looking for a non-surgical treatment for uterine fibroids.”

“We intend to meet with the FDA to discuss the Complete Response Letter and determine the potential next steps for our ulipristal acetate NDA,” Nicholson said in a statement.

The bad news for Allergan opens up a real possibility that AbbVie can beat it to market with its own treatment for women with uterine fibroids who experience abnormal bleeding. This morning the company released topline results from a Phase III trial that showed elagolix in combination with add-back therapy, reduced heavy menstrual bleeding for up to 12 months in women with uterine fibroids. The results were consistent with two other Phase III studies, AbbVie said. In July AbbVie and its development partner, Neurocrine, snagged FDA approval for elagolix as a treatment for endometriosis. The drug is now available for patients under the name Orilissa.

Allergan filed its NDA based off the results of two Phase III clinical trials that showed Esmya, a selective progesterone receptor modulator, benefitted women with abnormal bleeding. The drug’s clinical trial program included data from more than 700,000 women with uterine fibroids across 80 countries worldwide. The two Phase III studies included more than 500 women, the company said.

The CRL may have broader implications for Allergan than a rejected medication. Earlier this year, the company began to explore a potential sale of its women’s health business following a strategic review of the company. Chief Executive Officer Brent Saunders said earlier that the sale of the women’s health business was likely going to be delayed as potential buyers were waiting on the potential approval of Esmya in the United States. The women’s health business is valued at about $4 billion.

Shares of Allergan are down slightly in premarket trading to $189.11.

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