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Stelara: FDA and  EMA to ballot
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RegulatoryEUNetherlands

Stelara: FDA and EMA to ballot

10.12.2012 - J&J subsidiary Janssen pushes its antibody Stelara for approval against psoriatic arthritis. FDA and EMA will decide over the filed application.

The Johnson & Johnson subsidiaries Janssen Research & Development, LLC, and Janssen Biotech, Inc, from Horsham (USA) as well as Janssen Biologics B.V. from Leiden (The Netherlands) announced on 6 December the submission of a supplemental Biologics License Application (sBLA) to the United States Food and Drug Administration (FDA) and a Type II Variation to the European Medicines Agency (EMA), respectively. In both cases, the companies ask for the approval of Stelara (ustekinumab) for the treatment of adult patients with active psoriatic arthritis, a type of inflammatory arthritis that affects up to 30% of people suffering from psoriasis. Stelara is a human interleukin (IL)-12 and IL-23 antagonist, that is currently approved in 69 countries for the treatment of moderate to severe plaque psoriasis. After promising multicentre, randomised, double-blind, placebo-controlled Phase III trials (PSUMMIT I and II), J & J now hopes to expand the indication range for Stelara.

Jerome A. Boscia, Vice President at Janssen Research & Development, said: "The efficacy and safety of Stelara have been shown in a large Phase III clinical development programme for the treatment of active psoriatic arthritis, a disease for which tumour necrosis factor inhibitors are currently the only approved biologic therapies, and additional therapeutic options are needed." The trials included patients diagnosed with active psoriatic arthritis who had at least five tender and five swollen joints and C-reactive protein (CRP) levels of at least 0.3 mg/dl in spite of previous treatment with conventional therapy. Patients with previous exposure to tumour necrosis factor (TNF) inhibitors were also partially included. Stelara is also in a Phase III development for the treatment of moderately to severely active Crohn's disease.

Some weeks ago Janssen Biotech demonstrated its dedication to R&D by announcing collaborations with Danish Genmab A/S on the production of bi-specific antibodies as well as the development of daratumumab, a CD38 antibody.

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