Pfizer reported on Friday that it has seen 4 patients die in a phase III trial with its new rheumatoid arthritis (RA) drug, tofacitinib. Pfizer's shares dropped 3% and Abbott who markets a rival, Humira, went up 2% on the news. Pfizer is managing the news of the trial carefully as a result -- it says trial researchers only attribute one of the four deaths to the drug.
The results from the current trial, which will be presented at the annual meeting of the European League Against Rheumatism in May, are difficult to interpret because the number of patients who received a placebo is much smaller than those who got tofacitinib. Two of the deaths, a brain trauma and a case of rheumatoid arthritis that worsened after treatment was stopped, are clearly not linked to the drug. A third, a case of respiratory failure, was linked to tofacitinib by researchers.
What’s generating the most discussion is a death from acute heart failure. The researchers in the trial did not link this death to tofacitinib, but it according to Wells Fargo analyst Larry Biegelsen it is the fourth death of a patient from heart failure. The Food and Drug Administration is likely to pool heart failure deaths when it looks at tofacitinib.
The two key questions are whether tofacitinib will be approved, and whether it will compete directly with the existing injections (a bigger market) -- drugs like Humira, Enbrel, and Remicade or Simponi? Or will be used in patients who failed them (still a big market) as an oral dose alternative? This could be a multi-billion dollar question over the lifetime of the drug and one worthy of information management. See the Forbes blog.
Posted by Bruce Lehr April 25th 2011.