J&J Touts Psoriasis-Drug Data
By PETER LOFTUS [WSJ]
[SEPTEMBER 19, 2008]
Johnson & Johnson said its experimental drug ustekinumab was more effective at treating the skin disease psoriasis than Amgen Inc.'s blockbuster drug Enbrel in a J&J-funded patient study.
J&J, of New Brunswick, N.J., already has applied for Food and Drug Administration approval to market ustekinumab, supported by previous studies in which the drug was shown to be superior to a placebo in treating psoriasis. The newest study is unlikely to play a major role in the FDA's impending decision.
The FDA is expected to decide on ustekinumab by December, having extended its review in August to allow more time to examine amendments to J&J's application. An FDA advisory committee in June recommended the drug be approved, but the agency isn't bound by the panel's advice. Analysts expect the drug, if approved, to generate hundreds of millions of dollars in sales within a few years.
The latest data for ustekinumab were presented Thursday at a dermatologists' meeting in Paris. In the 903-patient trial, participants with moderate to severe psoriasis received one of two dose levels of ustekinumab, or Enbrel. The main goal was to track the proportion of patients in each group who achieved at least a 75% reduction in psoriasis at 12 weeks, as measured by an index assessing the surface area and severity of the disease, which causes skin lesions.
J&J said 68% of those taking the lower dose of ustekinumab and 74% taking the higher dose achieved at least a 75% reduction in disease, versus 57% of Enbrel users reaching that mark.
"We've never really seen clearance [of psoriasis] along the lines of what we've seen with ustekinumab," said Alan Menter, a dermatologist with Baylor Research Institute in Dallas and one of the trial's lead investigators. Dr. Menter said he has conducted research funded by other psoriasis-drug manufacturers, including Amgen.
Amgen spokeswoman Sonia Fiorenza said the study "does not address long-term safety" because it only lasted 12 weeks. She noted Enbrel has a "consistent safety profile" and 16 years of clinical experience.
Enbrel was introduced in 1998 as a treatment for rheumatoid arthritis. Following regulatory approval for additional uses including treatment of psoriasis, it is now one of the best-selling drugs in the world, with $5.3 billion in global sales last year, according to IMS Health.
Write to Peter Loftus at peter.loftus@dowjones.com |
