UPDATE: FDA Warns Biogen On Tysabri, Gilead On Truvada Promotions

The Food and Drug Administration said Wednesday that a promotional Webcast involving the multiple sclerosis drug Tysabri was "false or misleading" because it minimized the risk of a serious brain infection.

Tysabri is sold jointly by Elan Corp. (ELN, ELN.DB) and Biogen Idec Corp. (BIIB) to treat multiple sclerosis and Crohn's disease. In a March 25 letter sent to Biogen Idec, the FDA also cited the company for failing to submit the Webcast to the agency for review 30 days prior to using the material.

Separately, the agency cited Gilead Sciences Inc. (GILD) for a print advertisement involving its HIV drug Truvada. In a March 26 letter to Gilead, the FDA said the advertisement was "false or misleading" because it overstated the effectiveness of the products and minimized the risks associated with the drug.

Both letters were posted to the FDA's Web site on Wednesday.

The FDA said a Webcast conducted by Biogen Indec last October and November minimized the severity of the risk of developing progressive multifocal leukoencephalopathy or PML, a brain infection that's often fatal.

Tysabri was temporarily pulled from the market in 2005 after three patients in clinical trials contracted PML, and two patients died. In 2006, the FDA allowed Tysabri to return to the market with a risk-management program.

Naomi Aoki, Biogen Idec's director of public affairs, explained that the Webcasts were designed for doctors to discuss PML on a section of the company's Web site accessible only to health-care professionals.

"We believed that the content and means for communicating this safety information was appropriate, timely, factual and non-promotional, and we plan to have further conversation with the agency," she said.

The Webcasts were set up after European regulators disclosed a much higher number of PML cases than expected. Biogen Idec now updates PML numbers on a monthly basis.

The FDA said the ad for Truvada suggests the product is "better or more effective than has been demonstrated by substantial evidence or substantial clinical experience." The ad shows photographs of a woman who takes Truvada as part of her HIV combination therapy at various stages of her life, such as at her graduation, in an office setting reading a document and as a married woman sitting on a sofa. In each depiction, the woman appears to be happy and in good health.

The ad also says Truvada is proven over the long term to reduce HIV viral load to undetectable levels and increase counts of another type of cell involved with the body's immune system. The FDA said such claims haven't been demonstrated by substantial clinical evidence.

The agency also said the product "carries numerous serious, potentially life-threatening risks and adverse reactions...that can have a significant negative impact on a patient's life."

The FDA said Gilead needed to stop distributing the advertisement.

In a statement, Gilead said it takes the FDA's concerns regarding the advertisements seriously "and we will be working to respond to the FDA promptly."

-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; jennifer.corbett@dowjones.com

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