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Published on 8 January 2008

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EMEA and FDA approval sought for psoriasis treatment

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Applications have been submitted requesting approval of ustekinumab (CNTO 1275) in Europe and the USA for treating adult patients with chronic moderate to severe plaque psoriasis.

The announcement was made by drug firms Janssen-Cilag and Centocor, both part of the Johnson & Johnson group.

Belgian-based Janssen-Cilag has submitted a Marketing Authorisation Application to the EMEA, and US-based Centocor has submitted a Biologics License Application with the FDA.

Ustekinumab is a new human monoclonal antibody with a novel mechanism of action that targets the cytokines interleukin-12 (IL-12) and interleukin-23 (IL-23) – naturally occurring proteins that are important in regulating immune responses and are thought to be linked with some immune-mediated inflammatory disorders, including psoriasis.

An estimated 125 million people worldwide have psoriasis, including 2% of the European and US populations – that is, some 10 million Europeans and 7.5 million Americans.

Nearly one-quarter of people with psoriasis have cases that are considered moderate to severe, according to the US National Psoriasis Foundation.

The submissions are based on a development programme including data from two large phase 3 multicentre, randomised, double-blind, placebo-controlled trials involving some 2,000 patients that evaluated the drug’s safety and efficacy in treating moderate to severe plaque-type psoriasis.

The primary endpoint of each pivotal study was the proportion of patients who achieved at least a 75% reduction in psoriasis as measured by the Psoriasis Area and Severity Index (PASI 75).

Centocor clinical R&D chief Dr Jerome Boscia said: “We are very encouraged by the promising results that we have seen.”

US National Psoriasis Foundation statistics

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