Opinion ID: 203426
Heading Depth: 2
Heading Rank: 5

Heading: FDA Investigation and TYSABRI's Return to Market

Text: On March 7 and 8, 2006, the FDA's Peripheral and Central Nervous System Drugs Advisory Committee (Advisory Committee) held public hearings to evaluate the potential reintroduction of TYSABRI. In these hearings, Biogen and the FDA shared results of further testing and analysis, and various members of the public, including physicians and patients, gave comments. On June 5, 2006, the FDA approved TYSABRI's reintroduction into the market. The FDA's approval restricted TYSABRI to use as a monotherapy for relapsing forms of MS; it was not approved for use in combination with other drugs or for other diseases. Because of the potential risk of PML, TYSABRI was recommended only for those MS patients who do not respond to other MS treatment. Every MS patient using TYSABRI must enroll in a risk management program run by Biogen which closely monitors patients for any signs of PML. In addition, the package insert label includes a black-box warning, the strictest warning the FDA can require, which warns of the risk of PML. See 21 C.F.R. § 201.57(c)(1); see also CAC ¶ 17. In addition, the package insert label contains the following statement: The safety and efficacy of TYSABRI in combination with other antineoplastic, immunosuppressant, or immunomodulating agents have not been established. [9]