The European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) is advising physicians to inform their patients about a fatal case of progressive multifocal leukoencephalopathy (PML) in a patient being treated with dimethyl fumarate (Tecfidera, Biogen Idec) for multiple sclerosis (MS).
The case is the first of PML reported in association with this oral agent.
"The PRAC recommended that healthcare professionals and patients be informed and considered that there should be further evaluation of this case," a statement from the EMA released Friday noted.
A spokesperson for the EMA press office said that the brief statement was all the agency is prepared to say about the issue at this time.
George Scangos, PhD, chief executive officer of Biogen Idec, confirmed the PML case during the company's third quarter investors call October 22.
"We would like to inform you that we have confirmed a case of PML in a patient being treated with Tecfidera, who recently died of complications of pneumonia. Despite this tragic loss, we believe that the overall benefit-risk profile remains unchanged," he said.
The patient was treated with the drug for four and a half years as part of the ENDORSE study, he said. "During the course of therapy, the patient experienced severe lymphopenia that lasted for over three and a half years," he noted. "Lymphopenia is a known risk factor for PML and can be caused by a number of factors, including treatments for MS, cancer and HIV."
The current label includes warnings and precautions regarding lymphopenia, Dr Scangos added. "We reported the case to the regulatory authorities and will work with them to confirm that the language in our label provides patients and their physicians appropriate information regarding lymphopenia."
Asked for comment on this new development with the EMA, a spokesperson for Biogen Idec told Medscape Medical News, "We are in dialogue with regulators about the case, and will work with them to determine next steps."
The drug is the "number one oral MS treatment in the US," Dr Scangos said during the call, with more than 100,000 patients treated globally within 18 months of the US launch and in the only 6 months since the European approval, which he called "an impressive milestone."
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Cite this: Inform Patients of PML Case With Tecfidera in MS - Medscape - Nov 07, 2014.