European regulators have been investigating the safety of Allergan’s Esmya since December, and now they’re advising that no new patients start taking the drug until they wrap up their probe. And meanwhile? The drug is under review for FDA approval.
Friday, the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) advised that no new patients start taking the uterine fibroid drug “for the time being”—and that patients who have completed one course of treatment should hold off on starting a new one.
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As for women currently taking the drug, they should have a liver function test at least once a month while on treatment, the PRAC recommended. And if the test is abnormal, “the healthcare professional should stop treatment and closely monitor the patient,” it said, adding that liver tests should be repeated two to four weeks after stopping therapy.
The new warning is an update on the agency’s December announcement that it was reviewing the uterine fibroid drug after four cases of serious liver damage turned up among patients. Three of those cases ended in liver transplantation, the EMA said at the time.
Hungary's Gedeon Richter, which markets the drug in Europe, said in a Friday statement that it's "determined to work with PRAC and provide the necessary information to allow them to complete a fair assessment in a timely manner."
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It’s not a great sign for Allergan, which is chasing an approval for Esmya in the U.S. The Dublin drugmaker has said the product could become an anchor for its women’s health unit, potentially touching the blockbuster mark. And it’s coughing up the dough to help it get there: Esmya is going to get “a great deal of investment,” including 300 sales reps and a branded DTC campaign, marketing chief Bill Meury said in an October interview.
But the company, for its part, doesn’t foresee the ongoing European investigation affecting its chances at the FDA. “We do not believe there is a causal relationship between Esmya and liver transplantation,” a spokesman said in December, pointing out that no cases of liver transplantation cropped up in any of the controlled clinical trials for Esmya in the EU, Canada or the U.S.
An Allergan spokeswoman added Monday that "we continue to believe that the totality of the data for Esmya supports a positive benefit-risk profile. The FDA will make an independent decision based on all the available data.”