Genentech withdraws psoriasis drug from US market

Published: 13-Apr-2009

Raptiva associated with increased risk of progressive multifocal leukoencephalopathy

Genentech, a biotechnology company, has initiated a phased voluntary withdrawal of the psoriasis drug Raptiva from the US market.

The company's decision is based on the association of Raptiva with an increased risk of progressive multifocal leukoencephalopathy, a rare and usually fatal disease of the central nervous system. Raptiva is indicated for the treatment of chronic moderate-to-severe plaque psoriasis in adults 18 years or older who are candidates for systemic therapy or phototherapy.

According to the company, physicians should not issue prescriptions for Raptiva for any new patients and should promptly contact patients currently receiving Raptiva to assess the most appropriate treatment alternatives. Raptiva will no longer be available after June 8, 2009. This transition period is intended to allow patients, who are currently taking Raptiva, enough time to work with their doctors to appropriately discontinue use of Raptiva.

The company's actions have been taken after consultation with the FDA. Genentech is working with Merck Serono, its licensee outside the US and Japan to inform regulatory authorities outside of the US of Genentech's decision to withdraw Raptiva from the US market.

Hal Barron, chief medical officer of Genentech, said: Our decision to remove Raptiva from the market reflects Genentech's commitment to patient safety. 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.

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