Allergan confident in safety of Esmya despite liver injury reports in Europe

As Esmya is currently being reviewed by the FDA for the treatment of abnormal uterine bleeding in patients with uterine fibroids, four reported cases of serious liver injury sparked an investigation of the drug by the European Medicines Agency, or EMA.

Three of the cases resulted in liver transplantation, according to the EMA.

In an initial assessment, the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) hypothesized that Esmya (ulipristal acetate, Allergan) could have triggered the reports of liver injury. To determine the validity of such safety concerns for the use of ulipristal acetate, PRAC is currently evaluating all available data in a more in-depth review.

“FDA recently became aware of the EMA’s findings of reports of serious liver injury associated with ulipristal, however, we cannot comment at this time,” Jeremy Kahn, an FDA spokesman, told Healio Internal Medicine. “The FDA will monitor and review information about serious liver injury as it becomes available.”

In an interview with Healio Internal Medicine, Mark Marmur, an Allergan spokesman, said that it does not expect that the reports of serious liver injury in patients treated with ulipristal acetate in Europe will have an impact on its New Drug Application with the FDA.

Marmur noted that approximately 670,000 patients have been treated with ulipristal acetate since its release to the market in Europe in 2012. Allergan partners with the Hungary pharmaceutical company Gedeon Richter to market Esmya in Europe.

“We do not believe there is a causal relationship between Esmya and liver transplantation,” Marmur said. “There were no cases of liver transplantation in any of the controlled clinical trials for Esmya, including those for the European, Canadian and United States registrations.”

“Allergan and Gedeon Richter take patient safety seriously,” Marmur added. “We are confident in the safety profile of Esmya based on all available data collected from clinical studies and we remain committed to developing and providing this unique treatment option for women suffering from uterine fibroids.”

An EMA spokesperson told Healio Internal Medicine that the PRAC recommendations for the use of Esmya will be forwarded to the Committee for Medicinal Products for Human Use. The committee will form an opinion, then it may be adopted by the European Commission.

“Ulipristal acetate is also the active substance of a single-dose medicine authorised for emergency contraception, ellaOne,” the representative said. “No cases of serious liver injury have been reported with ellaOne and there are no concerns with this medicine at this time.” – by Alaina Tedesco

Editor’s note: This story has been updated to include comments from the EMA.

Disclosure: Healio Internal Medicine was unable to confirm relevant financial disclosures at the time of publication.