A panel of outsiders from the FDA in a 8-2 decision approved tofacitnib. The panel agreed in a 7-2 vote the drug was safe and 10-0 vote that the drug was effective. Usually the FDA follows the panel recommendations but doesn’t have to. A final decision on whether or not the drug should be approved will come August 21. The drug will be approved for rheumatoid arthritis. However, one possible use of this drug may be Crohn’s disease. Pfizer who makes the drug in their Q3 Earnings Call in 2011 said they were starting Phase III trials for ulcerative colitis and Phase II trials for Crohn’s.
One study done by Dr. William Sandborn at University at San Diego showed the tofacitnib was not that effective in Crohn’s. However, Edward Loftus Jr., gastroenterologist at the Mayo Clinic believes that it may be due to the low dosing that was given and that the story was too short to really see an effect.
Tofacitnib does seem to help people with ulcerative colitis however. The study showed that 76.3% of patients who took 15mg of the drug achieved a response which was much higher than the placebo group. One side effect was the drug did increase cholesterol levels and trilevels. However, I wonder if this can be managed through a cholesterol drug and or exercise.
One of the main advantages to tofacitnib is that unlike Humira, Remicade, or Enbrel it can be taken by pill form instead of being injected. Cost is another big issue. The cost of taking biologics such as Humira, Remicade, and Enbrel can be very costly.
Hopefully studies will show that tofacitnib will be effective in Crohn’s. Creating competition will be a good thing for the biologics since their patents never expire. More competition will create pricing wars which will bring down prices and increase quality.