J&J Says Psoriasis Drug Superior To Amgen's Enbrel
Dow Jones
September 18, 2008: 07:37 AM EST
Johnson & Johnson (JNJ) said its experimental drug ustekinumab was more effective at treating the skin disease psoriasis than Amgen Inc.'s (AMGN) blockbuster drug Enbrel in a J&J-funded patient study.
J&J, New Brunswick, N.J., already has applied for U.S. Food and Drug Administration approval to market ustekinumab, supported by previous studies in which the drug was shown to be superior to a fake drug 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 meeting of dermatologists 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 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. 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.
The proportion of study participants experiencing at least one side effect were comparable among the treatment groups. Those experiencing at least one serious adverse event totaled 1.9% among those on the lower dose of ustekinumab, 1.9% on the higher dose and 1.2% of those taking Enbrel.
A higher proportion of the Enbrel group experienced injection-site problems but that may have been influenced by the increased frequency of injections. Those taking ustekinumab were injected once at the start of the study and again at week 4, while those on Enbrel received twice-weekly doses for 12 weeks.
Enbrel was introduced in 1998 as a treatment for rheumatoid arthritis. Following regulatory approval for additional uses including psoriasis, it's now one of the best-selling drugs in the world, racking up $5.3 billion in global sales last year, according to IMS Health.
The ustekinumab-versus-Enbrel study was the first head-to-head trial of two so-called biologics in psoriasis treatment, J&J said. A biologic is a drug derived from a living organism and is typically injected or given by intravenous infusion, in contrast to more traditional pharmaceutical pills taken orally. In addition to Enbrel, which Amgen co-markets with Wyeth (WYE), other biologics approved to treat psoriasis include Astellas Pharma Inc.'s (4503.TO) Amevive, J& J's Remicade, Abbott Laboratories' (ABT) Humira and Genentech Inc.'s (DNA) Raptiva.
J&J said it had no plans to study ustekinumab in head-to-head trials versus Remicade.
Remicade, Enbrel and Humira belong to a class of drugs known as anti-tumor neucrosis factors, or anti-TNFs, which work by fighting inflammation in various parts of the body. Some also are approved to treat gastrointestinal disorders. Anti-TNFs are among the biggest-selling class of drugs, and carry high price tags.
Ustekinumab would be the first of a new class of anti-inflammatory drugs that target proteins called interleukins. Abbott Labs also is developing an anti- interleukin drug, ABT-874, which is being evaluated in a late-stage study of psoriasis patients.
The FDA has said this new class of drugs theoretically may carry an increased risk for malignancies and infections because the drugs suppress the immune system. However, studies so far haven't shown an increased risk of malignancies, though J&J is monitoring the long-term risk. Infection rates were similar between treatment groups in the latest study.
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