The health care giant released results of a Phase III study showing ustekinumab was just as safe and effective as the top-selling med sold by Amgen and Wyeth, which has a 75 percent share of the market, but required fewer injections.
Patients received either twice-weekly injections of Enbrel or 45 mg or 90 mg injections of the J&J drug at the start of the trial and four weeks later. After 12 weeks, 74 percent given the higher dose of ustekinumab and 68 percent on the lower dose saw at least a 75 percent reduction in psoriasis symptoms, such as red scaly patches. By comparison, 57 percent on Enbrel saw a similar reduction (here is the statement).
The drug works by blocking interleukin-12 and interleukin-23, which are proteins linked to inflammation in psoriasis and other autoimmune disorders. Last month, the FDA extended its review of ustekinumab to December to study additional submissions from J&J, but did not request additional clinical trials.
If approved, ustekinumab would compete with Enbrel, Abbott's Humira and J&J's own Remicade, which is given by intravenous infusion. These block a protein called tumor necrosis factor (TNF) that causes inflammation, which are effective, but raise the risk of infection and can reactivate tuberculosis, and some researchers believe they potentially increase the risk of cancer.
With assistance from Reuters
1 Comment
Geez, a double whammy. First the let down on the BIG Deno news and now, the announcement that J&J has a better drug for psoriasis than our beloved Enbrel which Amgen paid 17 billion dollars for Immunex, that hasn't made a very good profit due to the 50/50 share with Wyeth (USA and Canada) while the rest of the world, Wyeth gets it all and does nothing but sit back and clip the good ole coupons.
Next worry? What about their bonds?