Tysabri To Be Discussed At FDA Advisory Committee Meeting: Findings From The Briefing Documents (BIIB, ELN)

Today begins the two-day FDA Advisory Committee addressing the future of Biogen Idec’s (ticker: BIIB) and Elan’s (ticker: ELN) Tysabri. Over the past several months, The Biotech Stock Blog has had several posts speculating on the fate of this drug. Over the next couple days we will be a lot closer to understanding that fate. I have endured a considerable amount of criticism for voicing my opinions that went against popular sentiment. Apparently, I have not had enough – I am going to opine on Tysabri one more time.

Yesterday, the FDA released the Briefing Information for the Advisory Committee Meeting occurring today and tomorrow regarding the reintroduction of Tysabri back into the market. The most illuminating information to come from the documents was comments made by the FDA’s Office of Drug Safety (ODS) that stated: “It is the opinion of ODS that the RiskMAP* in its current form does not adequately address the risk of PML.