FDA Advisory Committee Supports Tysabri’s Return to Marketplace

March 16, 2006

Following the Food and Drug Administration’s (FDA) Peripheral and Central Nervous System Drugs Advisory Committee Meeting on March 7 and 8, 2006, members of the Committee decided that Tysabri’s effectiveness outweighs the potential for serious adverse events, recommending its return to the marketplace for treating individuals with the relapsing-remitting form of multiple sclerosis (MS).

Manufactured and marketed by Biogen Idec and Elan Corporation, Tysabri® (natalizumab) is an investigational drug being studied for the treatment of MS. It was given early approval in November 2004, but was voluntarily suspended three months later after progressive multifocal leukoencephalopathy (PML), an often-fatal brain disorder, was confirmed in two patients with MS taking both Tysabri and Avonex® (interferon beta-1a). The first patient died and the second patient survived in a debilitated state. A third case was discovered upon the re-examination of a patient who was given Tysabri for the treatment of Crohn’s disease and died in 2003. According to Biogen Idec and Elan, a comprehensive safety evaluation of more than 3,000 individuals who were given Tysabri yielded no new confirmed cases of PML.

Although the Advisory Committee’s recommendation does not guarantee that Tysabri will be approved, the FDA typically follows the recommendation of its Advisory Committees. A decision is expected by the end of March 2006. According to an FDA spokesperson, a risk-management plan for patients is being planned and a patient registry may also be set-up; additional patient-safety studies will be conducted as well.

MSAA was represented at the Advisory Committee Meeting by President and Chief Executive Officer Doug Franklin. In his remarks, Mr. Franklin advocated for many of the safety measures recommended by the Advisory Committee. Additionally, MSAA enthusiastically supports the development of new and more effective medications to treat MS, but at the same time, believes that patient safety must be a primary consideration. MSAA supports the FDA in its efforts to fully understand the benefits and risks prior to issuing this important ruling.

For More Information

The FDA provides the following links for additional information:

For further information, health care professionals and patients can visit FDA's website at: www.fda.gov/cder/drug/infopage/natalizumab/default.htm

Notice for the Peripheral and Central Nervous System Drugs Advisory Committee meeting: www.fda.gov/oc/advisory/accalendar/2006/cder12543d030706amd.html

Questions and Answers Regarding Lifting of the Clinical Hold on Tysabri (natalizumab)

For more information on Tysabri® from MSAA, please see:

"Antegren Update"

"FDA Approves Tysabri® (formerly Antegren) for the Treatment of Multiple Sclerosis"

"Voluntary Suspension of Tysabri® (Natalizumab) Marketing"

Revised Tysabri® Update: No New Cases of PML; Re-release Possible; Potential Risks Still a Concern

"Tysabri® Update: Trials Resume; Drug Remains off Market; FDA Holds Advisory Committee Meeting"

Anyone wishing additional information about MS and its treatments may contact MSAA's Helpline consultants by calling (800) 532-7667. Media questions should be directed to Andrea Borkowski at (800) 532-7667, ext. 123.

Written by Susan Wells Courtney, MSAA Senior Writer
Edited by Dr. Jack Burks, MSAA Vice President and Chief Medical Officer

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