J&J’s ‘ustekinumab’ may oust ‘Enbrel’ for psoriasis

On the basis of a patient study with regard to treating the skin disease – psoriasis - Johnson & Johnson (JNJ) said its experimental drug ‘ustekinumab’ was more effective than Amgen Inc.’s and Wyeth’s best-seller drug ‘Enbrel’. The latest data for ustekinumab was recently presented at a meeting of dermatologists in Paris.

In the trial study on 903 patients with moderate to severe psoriasis, these patients were given one of two dose levels of ustekinumab or Enbrel. The main aim was to track the proportion of patients in each group who achieved a minimum of 75% reduction in psoriasis in a 12-week period, measured according to an index assessing the surface area and severity of the disease, which causes skin lesions.

At the conclusion of the study analysis, J&J reported that while only 57% of patients given Enbrel doses achieved the targeted 75% reduction of psoriasis, 68% of the patients given the lower dose of ustekinumab and 74% of those given the higher dose registered similar results of 75% reduction.

It needs to be mentioned that Enbrel was introduced in 1998 as a treatment for rheumatoid arthritis. After its regulatory approval for additional uses including psoriasis, the drug is now one of the blockbuster drugs in the world. According to IMS Health, last year Enbrel racked up $5.3 billion in global sales. Analysts opine that if ‘ustekinumab’ gets approval from FDA, it will generate hundreds of millions of dollars in sales within first few years.

Dr. Alan Menter, a Baylor University dermatologist who led the study said: “I would anticipate, because of its robust clinical data and ease of administration, that once released, (ustekinumab) will certainly be a first-line drug for psoriasis.”

Expressing similar opinion, Matthew Dodds, Citigroup analyst, said that previous, separate trials had suggested ustekinumab was superior to Enbrel, “but this is the first time it has been demonstrated in a single study.” Dodds believes the new study, together with previous studies, “provides a compelling argument for FDA approval.”

However, it actually appears that the new study is unlikely to play a key role in the FDA’s impending decision concerning the approval to J&J to market ‘ustekinumab’, because of its alleged risk of cancer. Though an FDA advisory committee recommended in June that the drug be approved, the agency is in no way bound by the panel’s advice. In fact, in August, the FDA extended its review to allow more time to examine amendments to J&J’s application for approval, and it is now expected to decide on ‘ustekinumab’ by December.