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Novartis’ Cosentyx gets European approval for two conditions

pharmafile | October 23, 2015 | News story | Medical Communications, Sales and Marketing Cosentyx, European Medicines Agency, Novartis, psoriatic arthritis 

The scientific committee of the European Medicines Agency (EMA) has recommended the approval of Novartis’ Cosentyx (secukinumab) for treatment of ankylosing spondylitis (AS) and psoriatic arthritis (PsA).

Following two separate regulatory submissions, Cosentyx is now recommended for the treatment of active AS in adults who have responded inadequately to conventional therapy, such as non-steroidal anti-inflammatory drugs (NSAIDs), and for the treatment of active PsA in adult patients alone or in combination with methotrexate (MTX) when the response to previous disease modifying anti-rheumatic drug (DMARD) therapy has been inadequate.

Cosentyx is the first of a new class of medicines called interleukin-17A (IL-17A) inhibitors to be recommended for AS and PsA: conditions that affect around five million people in Europe. Both are life-long, painful and debilitating inflammatory diseases that affect the joints and/or spine. If not treated effectively, both conditions can lead to irreversible joint and/or spinal damage caused by years of inflammation.

David Epstein, division head, Novartis Pharmaceuticals, comments: “Novartis is pleased to be so close to bringing this life-changing medicine to people living with ankylosing spondylitis and psoriatic arthritis who are struggling to find the right treatment to control their symptoms. With Cosentyx, we have seen major and rapid reductions in the signs and symptoms of disease, including pain, disease progression and joint damage, paving the way for a potential new standard of care.”

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Novartis says new treatment options with alternative mechanisms of action are needed for both conditions, as many patients do not achieve an adequate response from standard treatments, such as DMARDs, NSAIDs or anti-TNF therapies.

Cosentyx Phase III studies have demonstrated significant improvements in the signs and symptoms of AS and PsA. Clinical improvements were seen as early as week three and through to week 52, with benefits reported across the spectrum of patients who have either never taken or who have had prior treatment with anti-TNF therapies.

The CHMP approval must be backed by the European Commission, which will usually do so within two months following CHMP opinion. One validated by the EC, the decision is applicable to all European Union and European Economic Area countries.

Cosentyx has been approved for the treatment of PsA in Japan since December 2014 and has received approval in 49 countries worldwide for the treatment of moderate-to-severe plaque psoriasis.

The drug is also approved in the US for the treatment of moderate-to-severe plaque psoriasis.

Joel Levy

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