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FDA rejects Allergan’s uterine fibroid drug over safety concerns

Its investigational drug has been linked to 'serious' liver damage issues in Europe


Allergan’s hopes of its investigational uterine fibroid drug hitting blockbuster status have taken a knock-back following a rejection on its marketing application by the US Food and Drug Administration (FDA).

In a complete response letter, the US regulator cited safety concerns regarding the drug’s post-marketing reports outside the US.

Allergan’s selective progesterone receptor modulator is already approved in Europe, where it is sold as Esmya (ulipristal acetate) and marketed by Hungarian pharmaceutical company Gedeon Richter.

It has been on the European market since 2012, but earlier this year the European Medicines Agency (EMA) implemented several safety measurements after reports of liver damage, including liver failure leading to transplantation, in those taking the drug.

The findings were backed up by the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC), which concluded that Esmya may have contributed to the development of some cases of serious liver injury.

The new measurements include contraindication in women with known liver problems, liver tests before, during and after treatment and liver monitoring literature.

In addition to this, the use of the medicine for more than one treatment course has been restricted to those who are not eligible for surgery.

The news isn’t great for Allergan, which has said it sees Esmya as a flagship brand for its women’s health unit, which remains a core focus for the group.

However, the company remains optimistic, and its chief research and development officer David Nicholson said Allergan “intends to meet with the FDA to discuss the complete response letter and determine the next steps for ulipristal acetate NDA”.

He added: “Allergan continues to believe in the need for novel treatment options for women who are looking for a non-surgical treatment for uterine fibroids.”

Article by
Gemma Jones

22nd August 2018

From: Regulatory



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