Johnson & Johnson is celebrating the news that it has received the backing of regulatory panel members in the USA for its psoriasis treatment ustekinumab.

The Dermatologic and Ophthalmic Drugs Advisory Committee of the US Food and Drug Administration has unanimously recommended (11-0) the approval of ustekinumab, a human monoclonal antibody that targets the cytokines interleukin-12 and -23, for the treatment of adult patients with moderate to severe plaque psoriasis.

The committee reviewed data from “one of the largest biologic clinical programmes in psoriasis”, said J&J, which included two Phase III trials involving more than 2,000 patients. Results of those studies showed that a majority of patients treated with ustekinumab experienced significant skin clearance by week 12 and sustained efficacy through at least week 76 with ustekinumab maintenance therapy every 12 weeks.

The DODAC have backed the drug despite evidence from trials in mice the drug may cause lymphomas after long-term use. The committee also advised the FDA to require J&J to track patients taking the drug for any signs of cancer and recommended that doctors administer ustekinumab in their clinics instead of patients taking the drug at home, like the current market leader, Amgen/Wyeth’s Enbrel (etanercept).

J&J has suggested setting up a voluntary registry of all patients prescribed the drug and to continue following participants in its trials for an additional five years. It is currently carrying out more long-term studies on the treatment.

One of the major advantages in using ustekinumab is that it requires less-frequent dosing than existing therapies. After an initial boosting phase, ustekinumab would be injected once every three months, while Enbrel needs to be taken twice a week. J&J’s existing blockbuster Remicade (infliximab), which is indicated for psoriasis, is administered every eight weeks, while Abbott Laboratories’ Humira (adalimumab) is taken every other week.

Red Cross legal battle settled
Meantime, J&J has settled its controversial legal dispute with the American Red Cross over the latter’s use of the famous emblem.

The case involved accusations by J&J and counterclaims by the ARC over the symbol that both have used for more than a century. The settlement means that both groups can continue to continue to use the red cross on a white background.

J&J chief executive William Weldon said that the firm “brought the lawsuit very reluctantly only to protect what we believed were important trademark issues". He added that the decision of the court “has brought clarity to those issues” so “we have no desire to continue our dispute through trial and appeal".