Novartis Secukinumab Receives EU Approval for nr-axSpA as Fourth Indication
Novartis
Drug Development and Manufacturing
European Commission
The European Commission, abbreviated as the EU Commission, is a supranational body under the European Union. Within the EU political system, the European Commission primarily undertakes executive tasks, thus being roughly equivalent to the government in a national system. However, the European Commission has other functions as well. In particular, except for the few circumstances specified in the treaties, the European Commission is the only institution with legislative power in the EU legislative process.
Yesterday (April 28), secukinumab was approved in China for the treatment of adult patients with ankylosing spondylitis who have had an inadequate response to conventional therapy. Today, further good news emerged regarding this drug.
Novartis Announces European Commission (EC) Approval of Secukinumab (Brand Name: Cosentyx; Commonly Known as "Secukinumab") for the Treatment of Adult Patients with Radiographic Negative Axial Spondyloarthritis (nr-axSpA)
This approval is based on data from PREVENT, a two-year, randomized, double-blind, placebo-controlled Phase 3 clinical trial, which enrolled 555 adult patients with active non-radiographic axial spondyloarthritis (nr-axSpA; onset before age 45, Visual Analog Scale [VAS] score ≥40/100, and Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] score ≥4). These patients had taken at least two different doses of nonsteroidal anti-inflammatory drugs (NSAIDs) within the four weeks prior to study initiation. Patients may have previously received treatment with no more than one TNF inhibitor but had demonstrated an inadequate response. Among the 555 patients, 501 (90.3%) were biologic-naïve. The primary endpoint of the study was the proportion of TNF inhibitor-naïve patients achieving an ASAS40 response with Cosentyx at Week 16 and Week 52.
Clinical trial results demonstrated that Cosentyx met its primary endpoint. Compared with placebo, 41.5% of patients with non-radiographic axial spondyloarthritis (nr-axSpA) treated with Cosentyx 150 mg exhibited a statistically significant and clinically meaningful reduction in disease activity (41.5% vs. 29.2%; p<0.05), achieving at least a 40% improvement in ASAS40 response at Week 16, with sustained improvement through Week 52. PREVENT is the largest biologic study ever conducted in patients with nr-axSpA.
Secukinumab is a fully human IgG1κ monoclonal antibody targeting IL-17A, developed by Novartis. It was approved by the FDA in 2015 and is currently available in more than 80 countries and regions, including the European Union and the United States. Its indications include psoriatic arthritis (PsA), plaque psoriasis (PsO), and ankylosing spondylitis (AS). Supported by five years of continuous efficacy and safety data, it has benefited over 300,000 patients worldwide.
Novartis stated in its press release that this approval underscores Cosentyx’s leadership in rheumatology and immunodermatology, with plans to expand its indications to 10 within the next decade.
*Disclaimer: This article was written by an author contributing to Sina Medical News. The views expressed are solely those of the author and do not represent the position of Sina Medical News.