EMEA suspends marketing authorisation for Merck's Raptiva

The European Medicines Agency (EMEA) has recommended to the European Commission that the marketing authorisation for Merck Serono's Raptiva (efalizumab) should be suspended.

Raptiva is currently approved for the treatment of adult patients with moderate to severe chronic plaque psoriasis who have failed to respond to, or who have a contraindication to, or are intolerant to certain other systemic therapies.

Merck Serono said the safety of patients is of utmost importance and the company will work closely with the European health authorities to undertake all necessary measures to comply with the EMEA recommendations.

Merck Serono's sales of Raptiva were Euro 93m in 2008 with a negative impact on profit. Merck completely wrote off rights for the drug for fiscal 2008.

Over the past five months, the company was notified of three virologically confirmed cases of progressive multifocal leukoencephalopathy (PML) in psoriasis patients treated with Raptiva. The first two were reported by Genentech, which markets Raptiva in the US. Those cases occurred in patients aged 70 or older, who received Raptiva for approximately four years. A third virologically confirmed PML case was recently reported in a patient aged 47 from Germany, who had been treated with Raptiva for more than three years. A fourth case suggestive of PML was previously reported, but not virologically confirmed.

The EMEA's Committee for Medicinal Products for Human Use (CHMP) has now concluded that the benefits of Raptiva no longer outweigh its risks.

In the EU, doctors have been advised not to issue any new prescriptions for Raptiva and review the treatment of patients currently receiving the medicine to assess the most appropriate alternatives. Patients who have been treated with Raptiva should be closely monitored for neurological symptoms and symptoms of infection.