According to a press release from Novartis, the European Commission (EC) has granted authorisation to secukinumab (Cosentyx). The drug can now be used to treat ankylosing spondylitis (AS), making it the first new treatment advance for AS in 16 years.
Prior to secukinumab, the most recent advance in AS treatment was the development of anti-tumor necrosis factor (anti-TNF) therapy, the current standard of care. Secukinumab has also been authorised for the treatment of psoriatic arthritis (PsA).
Secukinumab is the first in a new class of medicines—interleukin-17A (IL-17A) inhibitors—to be made available in Europe for AS and PsA. These authorisations follow on from the earlier licensing of secukinumab for the treatment of patients with moderate-to- severe plaque psoriasis.
Recent studies have shown that secukinumab provided a significant reduction in the signs and symptoms of AS as early as weeks 1-3, which were sustained over two years. Up to 80% of AS patients treated with secukinumab showed no progression of spinal damage as measured by x-ray over two years.
More than 9,600 patients have been treated with secukinumab in clinical trials across multiple indications, and over 12,500 patients with AS or PsA have been treated in the post-marketing setting. The safety profile of secukinumab was shown to be consistent with that seen in clinical trials across multiple indications.
The most frequently reported adverse drug reactions (ADRs) were upper respiratory tract infections (most frequently nasopharyngitis, rhinitis). Most of the reactions were mild or moderate in severity.
Secukinumab is now licensed to treat active AS in adults who have responded inadequately to conventional therapy, such as non-steroidal anti-inflammatory drugs.