J&J Unit Gets FDA Approval For Psoriasis Drug

NEW YORK (AP) — Johnson & Johnson's Centocor Ortho Biotech unit said Friday the Food and Drug Administration approved the drug Stelara as a treatment for severe plaque psoriasis.

Plaque Psoriasis is the most common type of psoriasis, which is a chronic skin condition with symptoms including inflamed red lesions that can cause pain. The company said about 7.5 million Americans have psoriasis.

In May, the Food and Drug Administration extended the review of Stelara by three months, though it didn't ask for more data. In December, the FDA delayed a ruling on the drug, asking for more information on the company's risk evaluation and mitigation strategy.

The injectable drug is also approved in the European Union, U.K., and Canada. The company has touted the benefit the drug can bring to psoriasis sufferers, as it can be administered less often than older drugs, with just five injections per year.

The drug enters an already competitive market. Thousand Oaks, Calif.-based Amgen Inc.'s rheumatoid arthritis and psoriasis drug Enbrel had sales of $899 million in the second quarter.