Janssen-Cilag: ustekinumab moves closer to psoriasis market leadership
24th November 2008
By Clare Davies
The CHMP has issued a positive opinion Janssen-Cilag's ustekinumab.
Ustekinumab is set for approval in Europe having received the backing of the Committee for Medicinal Products for Human Use. Janssen-Cilag's drug is highly anticipated by the dermatology community and with strong efficacy data and physician buy-in Datamonitor predicts that ustekinumab will become a market leader in psoriasis following its expected approval early next year.
Ustekinumab is a 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). This mechanism appears to show landmark efficacy in psoriasis, with clinical data from the bold head-to-head trial, ACCEPT, proving superiority to market leader Enbrel (etanercept).
This novel biologic to treat psoriasis from Janssen-Cilag (a Johnson & Johnson subsidiary) is now one step closer to approval in the EU. The European Committee for Medical Products for Human Use (CHMP) announced a positive opinion to the EMEA on November 21, 2008 while the Dermatologic and Ophthalmic Drugs Advisory Committee unanimously recommended ustekinumab for approval to the FDA in June. Datamonitor expects ustekinumab to gain approval in both the US and EU in the first quarter of 2009.
Psoriasis is estimated to affect nearly 17 million patients in the seven major markets (US, five EU and Japan). However, many are undiagnosed and only a small proportion of these suffer from the more severe form of this disease that is targeted by ustekinumab. Datamonitor estimates that approximately two million patients may be eligible for this therapy, and with an expected high price point in-line with other biologics, revenues will eclipse those of traditional treatments.
In a recent survey carried out by Datamonitor, ustekinumab was highly rated by 180 dermatologists across the seven major markets. Indeed, the drug was rated higher than existing therapies, including Enbrel and Remicade (infliximab) in terms of efficacy, maintenance of response and dosing frequency. Given that only clinical trial data is available at present, this research demonstrates how highly anticipated this product is within the market, a factor which is likely to help ustekinumab attain market leading status in the future.
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