Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced that the European Medicines Agency (EMEA) has recommended to the European Commission the suspension of the marketing authorization for Raptiva (efalizumab). 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.
The safety of patients is of utmost importance to Merck Serono. The company will work closely with the European health authorities to undertake all necessary measures to comply with the EMEA recommendations. Outside the European Union, in countries where Raptiva is marketed by Merck Serono, the company will contact the health authorities to inform them of the EMEA recommendation and determine appropriate actions.
Merck Serono's sales of Raptiva amounted to € 93 million in 2008 with a negative impact on Merck's profit. Already for the fiscal year 2008, Merck completely wrote off rights for the drug.
Over the past five months, Merck Serono was notified of three virologically confirmed cases of progressive multifocal leukoencephalopathy (PML) in psoriasis patients treated with Raptiva. The first two cases were reported by Genentech, which markets
Raptiva in the United States. 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. After reviewing a comprehensive benefit-risk re-assessment submitted by Merck Serono, 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 European Union, physicians should not issue any new prescriptions for Raptiva and should review the treatment of patients currently receiving the medicine to assess the most appropriate alternatives. They should make sure that patients who have been treated with Raptiva are closely monitored for neurological symptoms and symptoms of infection. Patients who are currently taking Raptiva should not stop treatment abruptly, but should make an appointment with their doctor to discuss appropriate treatment options.
Raptiva was approved in the European Union in 2004 for the treatment of adult patients with moderate to severe chronic plaque psoriasis who have failed to respond to, or who have a contra-indication to, or are intolerant to other systemic therapies including cyclosporine, methotrexate and PUVA. Since its approval in the United States in 2003, approximately 46,000 patients have been treated with Raptiva worldwide, based on data from clinical trials and post-marketing experience.
Raptiva (efalizumab) is a humanized therapeutic antibody designed to selectively and reversibly block the activation, reactivation and trafficking of T-cells that are critically involved in the psoriatic skin inflammation.