Merck KGaA reports severe adverse event in Raptiva patient

Merck KGaA and Merck Serono have announced that Genentech has reported a severe adverse event in a patient administered with Raptiva (efalizumb).

It said a 70-year old patient had experienced a case of progressive multifocal leukoencephalopathy after receiving the compound for over four years as a treatment for chronic plaque psoriasis.

Merck Serono has informed regulatory agencies outside Japan and the US of this serious adverse event, while ethics committees and study investigators are also being notified of the case.

The company said it is working in conjunction with the European Medicines Agency and other regulatory bodies in order to suitably update the product information.

It has also issued a “Dear Doctor Letter” to dermatologists and will determine if further action is needed.

Guy Braunstein, chief medical officer at Merck Serono, said: “Our primary concern is the safety of patients.”

He added the company has well-established processes and systems in place to monitor the safety of its drugs and to detect safety signals on a continuing patients.

Mr Braunstein said while this current incident appears to be an isolated case, the firm wants to ensure all relevant parties are made aware of it to facilitate informed treatment decisions.

In October 2006, Serono announced the results of a 24-week study of Raptiva in patients with moderate-to-severe psoriasis, with Raptiva confirming its safety and efficacy in these patients.