Johnson & Johnson's Stelara gains FDA approval for psoriatic arthritis

Janssen Research & Development, a subsidiary of US health care giant Johnson & Johnson (NYSE: JNJ), announced that the US Food and Drug Administration (FDA) has approved Stelara (ustekinumab) alone or in combination with methotrexate for the treatment of adult patients with active psoriatic arthritis.

For the treatment of psoriatic arthritis, Stelara is administered as a 45 mg subcutaneous injection at weeks 0 and 4, and then every 12 weeks, thereafter. The approval is supported by findings from two pivotal Phase III multicenter, randomized, double-blind, placebo-controlled trials of Ustekinumab, a fully human anti-il-12/23p40 monoclonal antibody, administered subcutaneously, in subjects with active psoriatic arthritis (PSUMMIT I and PSUMMIT II), which evaluated the efficacy and safety of subcutaneously-administered Stelara 45 mg or 90 mg at weeks 0, 4 and then every 12 weeks.

Cindy Guzzo, vice president, medical affairs, Janssen Biotech, said: "We're proud to expand our portfolio of biologic treatment options for patients living with psoriatic arthritis to include an anti-IL-12/23 therapy such as Stelara. The efficacy and safety profile of Stelara, coupled with a dosing regimen of every 12 weeks after two starter doses, makes this a meaningful new option for patients battling this chronic condition.”