EU approves Cosentyx (secukinumab) for ankylosing spondylitis- Novartis

Novartis announced that the European Commission (EC) has approved Cosentyx (secukinumab) for the treatment of people living with ankylosing spondylitis (AS). This is the first new treatment advance in 16 years since the development of the current standard of care, anti-tumor necrosis factor (anti-TNF) therapy. Approval was based on the pivotal Phase III studies MEASURE 1 and MEASURE 2 in the secukinumab clinical trial programme, which provided key data for the submission. Recent studies have shown that secukinumab provided a significant reduction in the signs and symptoms of AS as early as Week 1–3, which were sustained over two years. Up to 80% of AS patients treated with secukinumab showed no progression in spinal damage as measured by x-ray over two years.

Comment: There are few therapeutic options available to people with AS and there is a significant unmet need for alternative treatment options. Up to 70% of patients with severe AS develop spinal fusion over 10 to 15 years, which significantly reduces mobility. New treatment options are also urgently needed as many patients do not respond adequately to current medications such as non-steroidal anti-inflammatories and anti-TNF therapies, with up to 40% of patients not responding sufficiently to the latter.