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