STELARA Receives FDA Approval

STELARA™ (Ustekinumab) Receives Fda Approval For Treatment Of Moderate To Severe Plaque Psoriasis With Four-Times-A-Year Maintenance Dosing

First-in-Class Anti-IL-12/23 Biologic Targets Proteins Believed to Play a Role in Psoriasis

Horsham, PA (September 25, 2009) – Centocor Ortho Biotech Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved STELARA™ (ustekinumab) for the treatment of adult patients 18 years or older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.  The efficacy and safety of STELARA were evaluated in one of the largest clinical development programs for a biologic medication in the treatment of psoriasis.

STELARA is a first-in-class human monoclonal antibody that selectively targets the cytokines interleukin-12 (IL-12) and interleukin-23 (IL-23), naturally occurring proteins that are believed to play a role in the development of psoriasis.

“Findings from clinical studies showed that approximately seven out of 10 patients receiving STELARA achieved 75 percent skin clearance after just two doses, and maintained response for one year with continued treatment,” said Mark Lebwohl, MD, professor and chairman of the Department of Dermatology, The Mount Sinai School of Medicine, and study investigator.  “STELARA is a meaningful new option for patients with psoriasis that offers maintenance dosing every 12 weeks following two starter doses.”

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