Healthy Skepticism Library item: 7108

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Publication type: news

Biogen, Genentech Report Rituxan Deaths
The Street.com 2006 Dec 19
http://www.thestreet.com/_yahoo/newsanalysis/biotech/10328595.html?cm_ven=YAHOO&cm_cat=FREE&cm_ite=NA

Abstract:

Biogen Idec (BIIB – commentary – Cramer’s Take – Rating) and Genentech (DNA – commentary – Cramer’s Take – Rating) are issuing a “dear health care provider” letter to inform professionals that two patients have died while being treated with the companies’ Rituxan drug.

Biogen Idec said in a filing with the Securities and Exchange Commission on Monday that the patients died of progressive multifocal leukoencephalopathy, or PML, a rare, progressive, demyelinating disease of the central nervous system that usually leads to death or severe disability. While rare, PML is a known risk in patients who have immune system suppression either because of their disease or the medications they are taking, Biogen Idec said.
Rituxan was being used to treat Systemic Lupus Erythematosus, although the drug isn’t approved for treating SLE.

Biogen said the two patients had longstanding SLE with multiple courses of immunosuppressant therapy prior to receiving Rituxan. Rituxan monotherapy was the last treatment administered prior to the diagnosis of PML.

The companies are working with FDA to update the Rituxan prescribing information to include the new information.

Rituxan is indicated to treat certain non-Hodgkin’s lymphomas, leukemias and autoimmune disorders

Shares of Biogen Idec were off 5.4% in recent after-hours trading to $47.50; Genentech was 2.1% lower to $79.36.