07 Oct 2008 - 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...
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