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EU approves Cosentyx (secukinumab) for psoriatic arthritis- Novartis

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Last updated:24th Nov 2015
Published:24th Nov 2015
Source: Pharmawand

Novartis announced that the European Commission (EC) has approved Cosentyx (secukinumab) for the treatment of people living with psoriatic arthritis (PsA). Recent studies have shown that Cosentyx provided a significant reduction in the signs and symptoms of PsA as early as Week 1-3, which were sustained over two years and 84% of patients showed no progression of joint damage on x-ray over two years. The safety profile of Cosentyx was shown to be consistent with that seen in clinical trials across multiple indications. It is indicated for the treatment of active PsA in adult patients alone or in combination with methotrexate when the response to previous disease modifying anti-rheumatic drug therapy has been inadequate.

Pivotal Phase III studies in the Cosentyx clinical trial program, that provided key data for the submission, were FUTURE 1 and FUTURE 2 in PsA. These are ongoing multi-center, randomized, placebo-controlled studies that have been designed to evaluate the efficacy and safety of Cosentyx in PsA.

Comment: In total, 50 countries have approved Cosentyx for the treatment of moderate-to-severe plaque psoriasis which includes the European Union countries, Switzerland, Australia, the US and Canada. In Europe, Cosentyx is the only first-line biologic approved for the systemic treatment of moderate-to-severe plaque psoriasis in adult patients. In the US, Cosentyx is approved as a treatment for moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy (light therapy). In Japan, Cosentyx is approved for the treatment of moderate-to-severe plaque psoriasis and also for the treatment of PsA. In Ecuador, Cosentyx is approved for the treatment of PsA and AS.

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