Centocor and Janssen-Cilag submit regulatory applications for ustekinumab

Centocor and Janssen-Cilag have submitted regulatory applications requesting the approval of ustekinumab (CNT0 1275) in the US and Europe for the treatment of patients with moderate to severe plaque psoriasis.

Centocor has submitted a Biologics Licence with the US Food and Drug Administration while Janssen-Cilag has submitted a Marketing Authorisation Application to the European Medicines Agency.

The submissions are based on results from a development programme which includes data from two large Phase III trials involving nearly 2,000 patients.

Trials evaluated the safety and efficacy of its biologic therapy ustekinumab in the treatment of moderate to severe plaque-type psoriasis with the results showing patients achieving at least a 75 per cent reduction in psoriasis as measured by the Psoriasis Area and Severity Index.

Jerome A Boscia, senior vice-president of clinical research & development at Centocor, stated that the companies were encouraged by the “promising results” that had been seen throughout the clinical development programme.

“We remain committed to developing safe and effective new therapies for patients with inflammatory diseases like psoriasis through continued research and development in disease areas where unmet,” he confirmed.

Earlier this year, Centocor presented results of the ustekinumab Phase III trial at the World Congress of Dermatology, showing that it significantly improved psoriasis.