New Brunswick, N.J. ? A Johnson & Johnson-funded patient study suggests that J&J?s experimental drug ustekinumab was more effective at treating psoriasis than Amgen?s Enbrel, the Wall Street Journal reports.
New Brunswick, N.J. — A Johnson & Johnson-funded patient study suggests that J&J’s experimental drug ustekinumab was more effective at treating psoriasis than Amgen’s Enbrel, the Wall Street Journal reports.
New Brunswick-based J&J has applied for Food and Drug Administration (FDA) 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 ultimate decision, the Journal reports.
The FDA is expected to issue its decision on ustekinumab by December, having extended its review in August to allow more time to examine amendments to J&J’s application. In June, an FDA advisory committee recommended approval, but the agency isn’t bound by the panel’s recommendation.
In the 903-patient trial, participants with moderate to severe psoriasis received one of two dose levels of either ustekinumab or Enbrel. One of the goals was to track the proportion of patients in each group who achieved at least a 75 percent reduction in psoriasis at 12 weeks, as measured by an index assessing the surface area and severity of the disease.
According to J&J, 68 percent of those taking the lower dose of ustekinumab and 74 percent taking the higher dose achieved at least a 75 percent reduction in the disease, versus 57 percent of Enbrel users.
The Journal notes that an Amgen spokeswoman said the study “does not address long-term safety” because the study lasted only 12 weeks, and noted that Enbrel has a “consistent safety profile” and 16 years of clinical experience.
Enbrel was introduced 10 years ago as a treatment for rheumatoid arthritis, then earned FDA approval for additional uses, including treatment of psoriasis. The Journal reports that Enbrel is now one of the best-selling drugs in the world, with $5.3 billion in global sales last year, IMS Health reports.