Nov 24 2008
Janssen-Cilag announced today that ustekinumab, the first in a new class of biologics, has received a positive opinion for the treatment of moderate to severe plaque psoriasis from the European Committee for Medical Products for Human Use (CHMP).
This positive opinion takes patients living with the physical and mental burdens of psoriasis a step closer towards a convenient new therapeutic option. The CHMP's positive opinion is now referred for final action to the European Commission.
The CHMP recommended approval of ustekinumab is for adults who have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA (a light sensitising medication, combined with exposure to ultraviolet light A).
This positive opinion is based on data from two large pivotal Phase 3 (PHOENIX 1 & 2), multi-centre, randomised, double blind, placebo controlled trials involving nearly 2,000 patients in whom the efficacy and tolerability of ustekinumab in the treatment of moderate to severe plaque psoriasis was evaluated. More than two-thirds of patients achieved the primary endpoint of each pivotal study, at least 75% reduction in psoriasis using the Psoriasis and Severity Index (PASI 75) at week 12, after just two doses at weeks 0 and 4. Significant maintenance of PASI 75 response through at least one year in patients receiving maintenance therapy every 12 weeks was also demonstrated using a randomised withdrawal design in the first pivotal study (PHOENIX 1). Rates of serious adverse events, including serious infections, malignancies and cardiovascular events, were low and consistent with the expected background rates. The most common adverse events in Phase 3 clinical trials were arthralgia, cough, headache, injection site erythema, nasopharyngitis and upper respiratory tract infection.
Psoriasis is a chronic, immune-mediated inflammatory disease, which results from the over-production of skin cells resulting in their accumulation on the surface of the skin, which causes red, scaly plaques that may itch and bleed. It is estimated that three percent of the world's population has psoriasis. Twenty to thirty percent of people with psoriasis have cases that are considered severe.
Ustekinumab is a new, human monoclonal antibody with a novel mechanism of action that targets the p40 sub-unit of cytokines interleukin-12 (IL-12) and interleukin-23 (IL-23), naturally occurring proteins that are important in regulating immune responses and that are thought to be associated with some immune-mediated inflammatory disorders, including plaque psoriasis. Ustekinumab is under regulatory review in the United States.
Centocor, Inc. developed ustekinumab and has exclusive marketing rights to the product in the United States. Janssen-Cilag companies have exclusive marketing rights in all countries outside of the United States.