Merck Serono: Severe Adverse Event Reported in Raptiva Patient
Merck KGaA, together with its Merck Serono division, announced that Genentech Inc. has reported a case of progressive multifocal leukoencephalopathy (PML) in a 70-year old patient who had received Raptiva® (efalizumab) for more than four years of treatment of chronic plaque psoriasis. Genentech markets Raptiva® in the United States.
In accordance with regulatory requirements, Merck Serono has informed regulatory agencies in its marketing territories outside the U.S. and Japan about this serious adverse event. Study investigators and ethics committees are being notified of this PML case. Merck Serono is working diligently with the European Medicines Agency (EMEA) and other regulatory agencies to update the product information accordingly, issue a ‘Dear Doctor Letter’ to all dermatologists and to determine if further action is needed.
“Our primary concern is the safety of patients,” said Guy Braunstein, Chief Medical Officer Merck Serono. “We have well-established systems and processes in place to monitor the safety of our medical products and to detect safety signals on an ongoing basis. Although this appears to be an isolated case among more than 46,000 patients treated with Raptiva® we want to ensure investigators and prescribers are made aware, so that they can make informed treatment decisions.”
The case in the United States was reported to Genentech in late September as part of the company’s ongoing safety monitoring and surveillance program. Based on the medical information available to date, it cannot be excluded that Raptiva® may have had a contributory role in the development of PML in this patient. There are no other cases of confirmed PML in patients treated with Raptiva®. Previously, there has been a report by Genentech of a 62-year old patient treated with Raptiva in the United States who developed progressive neurologic symptoms and died of an unknown cause.
Patients who are currently on Raptiva therapy should discuss the benefits and risks of Raptiva with their physicians. It is important for patients not to change or stop treatment without first talking with their physician. Physicians are advised to follow the guidance provided in the Summary of Product Characteristics (SmPC) when switching or stopping treatment with Raptiva.
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