Pharmaprojects R&D Pipeline News Feed
Suspension of marketing of Raptiva in Europe
27 Feb 2009
The European Medicines Agency (EMEA) has recommended that the European Commission suspend marketing authorisation for Raptiva (efalizumab), a humanised anti-CD11a monoclonal antibody approved for the treatment of moderate-to-severe chronic plaque psoriasis, following a number of cases of progressive multifocal leucoencephalopathy (PML) in patients receiving the therapy.
In November 2008, the European Commission approved updated product information to include PML warnings initially raised by Genentech, which markets Raptiva in the US, following one case there. The recent EMEA recommendation follows a second case of PML in the US and a third in Germany. In the US, Genentech issued a 'Dear Healthcare Provider' letter in October 2008 and a US FDA black box warning request is currently under review.
PML is a progressive demyelinating disease of the central nervous system, caused by activation of the John Cunningham virus (latent in up to 80% of adults) in conditions of immunodeficiency or immunosuppression. No treatment currently exists for PML. The US cases occurred in patients aged 70 years or older, who had received Raptiva for approximately four years. The recent case in Germany occurred in a 47 year old patient, who had been treated with Raptiva for more than three years In the initial US case the patient died of unknown causes after suffering progressive neurological symptoms.
In a similar case, Tysabri (natalizumab), a humanised monoclonal antibody first approved in the US for relapsing-remitting multiple sclerosis, was withdrawn from the market in 2005 following fatal reports of PML in treated patients. In all cases, Tysabri had been taken in combination with one or more additional immunomodulating drugs. It was re-approved by the US FDA in 2006 after lobbying by patient advocacy groups, with the proviso of being administered under supervision and subsequently closely monitored.
