Elan held its Annual General Meeting today, and amidst the financial discussions, mentioned a few interesting tidbits about Tysabri. The bottomline good news for MS'ers is that all indications show the promising but controversial therapy will be available to patients in the second half of this year in both the United States and Europe.
More specifically, Elan said that the drug was still on track for final review by June 28th, 2006, which was the United States FDA's extended deadline for determining the medication's fate and "finalized" risk profile. Recall that though the FDA's advisory committee recommended the drug be re-introduced, the FDA..
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... asked for an extension in order to better define the risk management plan versus the often-fatal PML infection. PML was seen in 3 Tysabri + Avonex trial patients, 2 of the cases fatal, causing the original cessation of marketing nearly 2 years ago.
Elan also held open the option that the decision could be made earlier than the deadline--
"Elan and Biogen and the agency (the FDA) have indicated that if we can achieve clarity sooner than that we will do that," Elan's Chief Executive Officer Kelly Martin said.
Finally, comments made indicated that Elan and Biogen might consider raising the price of Tysabri, given recent price increases nearly across the board of existing therapies.
"We would need to see the drug's final risk profile before setting a price...clearly there's headroom to raise the price, but we haven't finalised that."
Tysabri originally had a wholesale price of nearly $1,800 USD a dose, or upwards of $23,000 USD per year of therapy. By comparison, pricing for competing therapies (prior to the aforementioned recent hikes) were as follows: $16,608 (Avonex), $20,553 (Rebif), $16,026 (Copaxone), and $17,827 (Betaseron).
Sources
Elan, Biogen mull price rise for MS drug Tysabri
National MS Society Research Bulletin on Tysabri
