? EMEA Recommends Suspension of marketing authorisation (MA) of efalizumab (RaptivaTM) due to potentials for severe side effects.
The European drug regulatory body recommends suspension of the marketing authorisation of Raptiva (efalizumab) The European Medicines Agency (EMEA) has recommended the suspension of the marketing authorisation for Raptiva (efalizumab), from Serono.
The EMEA’s Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Raptiva no longer outweigh its risks, because of safety concerns, including the occurrence of progressive multifocal leukoencephalopathy (PML) in patients taking the medicine. Read EMEA's statement here. Raptiva has been authorised in the European Union (EU) since September 2004 to treat adult patients with moderate to severe chronic plaque psoriasis (a disease causing red, scaly patches on the skin), who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA (psoralen ultraviolet-A).
Singapore drug regulatory body - HSA - has requested the licence holder to halt the sales of the same drug here; and on 26-Feb-2009, a press release about the local regulatory action taken against efalizumab was issued. To read more, click here.
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