Johnson & Johnson subsidiaries Centocor and Janssen-Cilag say that they have requested approval of their eagerly-anticipated new compound ustekinumab in the USA and Europe, respectively, for the treatment of adults with plaque psoriasis.
Ustekinumab is a human monoclonal antibody with a novel mechanism of action that targets the cytokines interleukin-12 and IL-23, naturally occurring proteins that are important in regulating immune responses and that are thought to be associated with some inflammatory disorders, including psoriasis.
The submissions are based on what the two firms describe as “a comprehensive development programme”, including data from two large Phase III trials. The primary endpoint of each pivotal study was the proportion of patients who achieved at least a 75 percent reduction in psoriasis as measured by the Psoriasis Area and Severity Index (PASI 75).
“We are very encouraged by the promising results that we have seen through the ustekinumab clinical development programme evaluating the efficacy and safety of this novel biologic in the treatment of moderate to severe plaque psoriasis,” said Jerome Boscia, senior vice president of clinical R&D at Centocor.
It is estimated that 125 million people worldwide have psoriasis, including 7.5 million Americans and 10 million Europeans. Nearly one-quarter of people with psoriasis have cases that are considered moderate to severe.
The new drug appears to have the same efficacy as anti-tumour necrosis factor therapies used for psoriasis such as J&J’s existing blockbuster Remicade (infliximab) and Amgen’s Enbrel (etanercept) but without the side effects associated with the latter drugs, such as infections. Also, ustekinumab is self-injectable and can be given less frequently than Enbrel, while Remicade requires a two-hour intravenous infusion at a doctor’s
