Green light in EU for Novartis’ Cosentyx

The European Commission (EC) has approved Novartis’ Cosentyx (secukinumab) for the treatment of people living with ankylosing spondylitis (AS) and psoriatic arthritis (PsA).

Novartis on Monday said this was the first new treatment advance for AS in 16 years since the development of the current standard of care, anti-tumor necrosis factor (anti-TNF) therapy.

As said in Novartis’ press release, Cosentyx is the first in a new class of medicines called interleukin-17A (IL-17A) inhibitors to be made available in Europe for AS and PsA. These approvals follow on from the earlier EC approval of Cosentyx for the first-line treatment of patients with moderate-to-severe plaque psoriasis, the company noted.

“Cosentyx may give patients the chance to stop the disease from progressing, preventing living with pain and disability,” said David Epstein, Division Head, Novartis Pharmaceuticals.

“These approvals mean that people living with ankylosing spondylitis and psoriatic arthritis across Europe can now start to benefit from this next generation biologic that has the potential to become a new standard of care for these common but under-treated inflammatory conditions.”

Cosentyx reduces sings of AS or PsA symptoms

Recent studies have shown that Cosentyx provided a significant reduction in the signs and symptoms of AS or PsA as early as Week 1-3, which were sustained over two years2,3. Up to 80% of AS patients treated with Cosentyx showed no progression in spinal damage as measured by x-ray over two years. In PsA, 84% of patients showed no progression of joint damage on x-ray over two years.

Novartis noted that more than 9,600 patients have been treated with Cosentyx in clinical trials across multiple indications, and over 12,500 patients have been treated in the post-marketing setting14. The safety profile of Cosentyx was shown to be consistent with that seen in clinical trials across multiple indications2-5,14, Novartis added.

Cosentyx is now licensed to treat active AS in adults who have responded inadequately to conventional therapy, such as non-steroidal anti-inflammatory drugs, and 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 MEASURE 1 and MEASURE 2 in AS, and FUTURE 1 and FUTURE 2 in PsA2,3,15,16.