Genentech withdraws Raptiva from the US market

Genentech is to start a phased voluntary withdrawal of the psoriasis drug Raptiva (efalizumab) from the US market. The company's decision is based on the association of Raptiva with an increased risk of progressive multifocal leukoencephalopathy (PML), a rare and usually fatal disease of the central nervous system.

Effective immediately, doctors are being advised not to issue prescriptions for Raptiva for any new patients and to review the treatment of patients currently receiving the medicine to assess the most appropriate alternatives. Raptiva will no longer be available in the US after 8 June.

Genentech estimates that approximately 2,000 patients in the US may currently be receiving Raptiva. Since FDA approval in 2003, approximately 46,000 patients worldwide have been treated with this drug.

"Our decision to remove Raptiva from the market reflects Genentech's commitment to patient safety," said Hal Barron, Genentech's senior vice president of development and chief medical officer. "Although we believe that many psoriasis patients are benefiting from Raptiva, the balance between benefit and risk in the psoriasis population for which Raptiva was approved has significantly changed."

The Raptiva prescribing information was updated in October 2008 to include a boxed warning on the risk of serious infections, including PML, in patients using the drug. The Raptiva prescribing information was further updated in March 2009 to include additional information on the risk of PML and a new Medication Guide for patients.

There have been three cases of diagnosed PML in patients receiving Raptiva and one patient treated with the drug who developed progressive neurologic symptoms and died of unknown causes. It is not known whether other, unreported cases have occurred.

The decision to withdraw the drug from the US market has been taken after consultation with the US Food and Drug Administration.

Genentech is working with Merck Serono, its licensee outside the US and Japan, to inform regulatory authorities outside the US of its decision.

In February, the European Medicines Agency (EMEA) recommended to the European Commission that the marketing authorisation for Raptiva should be suspended.

The EMEA's Committee for Medicinal Products for Human use had concluded that the benefits of Raptiva no longer outweighed its risks.

Doctors in the EU have already been advised not to issue any new prescriptions for Raptiva and to assess the most appropriate alternatives for those taking the medicine.

In 2008, US sales of Raptiva were approximately US$108m (Euro 81m). As a result of the phased withdrawal and resultant excess stocks, Genentech will report a one-time charge of approximately US$125m (â"šÂ¬94m) in its results for the first half of 2009.