Prudential Report Today on Tysabri.
• This morning Biogen Idec and partner Elan released the top line 2 year data from the AFFIRM monotherapy trial.
• While not directly comparable to competitive compounds, the data from AFFIRM appears consistent with the 1 year data in terms of reduction in relapse rate and safety.
• By our analysis, the reduction in relapse rate for both the one year and 2 year data appear to be approximately twice that of each of the interferon compounds (Avonex, Rebif and Betaseron), as well as Copaxone.
• With respect to disability progression, Tysabri demonstrated a hazard ratio of 42% compared to placebo. Recall that neither Betaseron nor Copaxone have a disability claim in their respective labels.
• We learned from Biogen Idec management that when the full data set is presented at the upcoming AAN (American Academy of Neurology) on April 12 and 13 in Miami, the data will be sliced in various ways which will allow a direct comparison to the labels of the competitive compounds listed above.
• We view this as an indication of Biogen Idec confidence in the superiority of their data over the competitive set.
Typical of Biogen- slicing the data.
The only way we can tell if Tysabri is any better at reducing disability than CRABs is by trying to analyze it the same way it was done in the trials that used the CRABS (i.e., slicing it differently).
HarryZ, I thought you'd be happy - you were forever complaining that:
1.) There's no disability data
2.) They're not releasing the 2-year data.
3.) The FDA shouldn't have approved it, and the 2-year data will be different.
Now, granted, I may be biased toward that drug, since it's my wife only real hope of staving off MS using current drugs.
But surely, isn't it time to express some joy at the good news?
The disability data I am looking for is the EDSS scores which I am told is the real measurement for these drugs. From what I have been told by people in MS medicine,that did not improve in the trials. Biogen has still not published that data yet.
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