FDA to take 3 additional months for its review of ustekimumab for psoriasis

The U.S. Food and Drug Administration (FDA), which is reviewing whether to approve the experimental biologic ustekinumab for the treatment of moderate to severe plaque psoriasis, will take an additional three months before it renders its decision. This means we can expect a decision by the FDA near the end of 2008.

At a June 2008 FDA Advisory Committee Hearing, a panel of outside experts unanimously recommended approval of ustekinumab. (Psoriasis Cure Now appeared at the Hearing and urged that the treatment be made available to patients.) The FDA typically follows the advice of its advisory committees but is not required to do so.

Centocor discovered ustekinumab and will market it in the United States, probably under the brand name Stelara.