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Novartis’ Cosentyx on course for new European indications

CHMP recommends its approval to treat ankylosing spondylitis and psoriatic arthritis

European regulatory advisors have given positive opinions for Novartis' Cosentyx for the treatment of ankylosing spondylitis and psoriatic arthritis.

Phase III studies on Cosentyx (secukinumab) have demonstrated significant improvement in the signs and symptoms of ankylosing spondylitis (AS) and psoriatic arthritis (PsA) with some improvements seen as early as three weeks after treatment.

David Epstein, division head of Novartis, said: “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.

Current treatment options for both conditions usually involve DMARDs, NSAIDs, or anti-TNF therapies and it is seen that new treatment options with alternative methods of working are required. 

It is estimated that 45% of PsA patients and 40% of AS patients are dissatisfied, do not respond or do not tolerate current treatments. 

The CHMP recommendation for Cosentyx is a 150mg subcutaneous injection with dosing for the first four weeks followed by monthly maintenance dosing. AS is a painful, progressively debilitating condition caused by inflammation of the spine. Around 70% of patients affected develop spinal fusion, which dramatically reduces mobility and quality of life. 

PsA is part of a family of diseases that has a negative impact on joints. There are approximately 3.1 million people in Europe with the condition and as many as one in four people with psoriasis may have undiagnosed PsA. 

Article by
Nikhil Patel

26th October 2015

From: Regulatory



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