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EU and FDA thumbs-up for J&J's Stelara for PsA

Daily News | September 24, 2013

Kevin Grogan

EU and FDA thumbs-up for J&J's Stelara for PsA

Regulators on both sides of the Atlantic have given the green light to Johnson & Johnson's Stelara as a treatment for psoriatic arthritis.

The approval for Stelara (ustekinumab) from the US Food and Drug Administration and the European Medicines Agency is for its use alone or in combination with methotrexate for the treatment of adults with PsA. The thumbs-up is based on the Phase III PSUMMIT studies which, according to Jerome Boscia, head of immunology R&D at J&J's Janssen unit represented one of the largest clinical development programmes ever conducted for the disease.
He added that the approval in the USA makes Stelara "the first treatment approved for this devastating and complex disease since the introduction of anti-TNF biologic medicines more than a decade ago". The company quoted Alice Gottlieb at Tufts Medical Center as saying that "therapy that targets the cytokines interleukin-12 and interleukin-23, two naturally occurring proteins believed to play a role in the development of this debilitating immune-mediated inflammatory disease, could improve patient care". The drug is already available for psoriasis.

On a good day for J&J, the European Commission has approved Simponi (golimumab), the firm's rheumatoid arthritis drug, as a treatment for ulcerative colitis.

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