Research & Development
Janssen-Cilag International NV passes EC's approval for TREMFYA for treating moderate to severe plaque psoriasis in the EU
24 November 2017 -

Healthcare company Janssen-Cilag International NV reported on Thursday the receipt of European Commission's (EC) approval for TREMFYA (guselkumab) for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy.

This EC approval allows for the marketing of TREMFYA (guselkumab) in all 28 member states of the EU as well as the European Economic Area countries (Norway, Iceland and Liechtenstein).

The company said guselkumab is the first biologic that selectively blocks interleukin (IL)-23, a key driver of the immune inflammatory response in psoriasis. Guselkumab is a self-injectable treatment that requires two starter doses, one initially and the other four weeks later, followed by a maintenance dose once every eight weeks thereafter.

This EC approval is based on data from the company's three Phase III clinical studies. The VOYAGE 1 and 2 trials, which compared guselkumab with placebo and HUMIRA (adalimumab), showed high levels of skin clearance after just 16 weeks, with at least a 90% reduction in Psoriasis Area and Severity Index score (PASI 90).

In addition, the company's NAVIGATE trial evaluated patients who did not achieve a response of cleared or minimal disease (Investigator's Global Assessment [IGA] score of 0 or one) by week 16 when treated with STELARA (ustekinumab) and were then randomised to either switch to guselkumab or continue on ustekinumab. The guselkumab group patients achieved an IGA score of 0 or one and at least a two-grade improvement from week 28 through week 40, compared to the ustekinumab group.

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