Novartis Announces FDA Approval of Cosentyx® (Secukinumab) for Active Non-Radiographic Axial Spondyloarthritis – Fourth Indication in the U.S.

June 17, 2020 /BioValleyBIOON/ --Novartis(Novartis) recently announced that the U.S. Food and Drug Administration (FDA) has approved the anti-inflammatory drug Cosentyx (Chinese brand name: Keshanting; generic name: secukinumab, commonly known as "Su Jin Monoclonal Antibody") for the treatment of adult patients with active radiographic-negative axial spondyloarthritis (nr-axSpA).

In April this year, Cosentyx was approved in Europe, becoming the first IL-17A inhibitor for the treatment of nr-axSpA. In the United States,Eli LillyTaltz (ixekizumab) was approved in early June, becoming the first IL-17A inhibitor approved in the U.S. market for the treatment of nr-axSpA.

Previously, Cosentyx had been approved for three indications: psoriatic arthritis (PsA), plaque psoriasis (PsO), and ankylosing spondylitis (AS). The approval for nr-axSpA marks the fourth indication for Cosentyx, addressing the entire disease spectrum of axial spondyloarthritis (axSpA), including both AS and nr-axSpA. It is estimated that approximately 2.7 million people in the United States suffer from axSpA; however, this condition remains significantly underdiagnosed.

Clinical data demonstrate that, compared with placebo, patients treated with Cosentyx experienced a significant reduction in disease activity. Notably, Cosentyx showed clinically meaningful results as early as Week 3, which were maintained for up to one year. With this approval, Cosentyx will provide an important treatment option for this condition, which currently has limited therapeutic alternatives.

This approval is based on the efficacy and safety results from the Phase III clinical study PREVENT (NCT02696031). PREVENT is the largest-scale study evaluating a biologic agent for the treatment of patients with non-radiographic axial spondyloarthritis (nr-axSpA). This randomized, double-blind, placebo-controlled study was designed to investigate the efficacy and safety of Cosentyx in patients with active nr-axSpA. The study enrolled 555 patients with active nr-axSpA (disease onset before age 45, spinal pain score ≥40/100 on the Visual Analog Scale [VAS], and Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] ≥4), who had previously received treatment with at least two different nonsteroidal anti-inflammatory drugs (NSAIDs) at the maximum tolerated dose for 4 weeks prior to the study, and may have had an inadequate response to no more than one tumor necrosis factor (TNF) inhibitor.

Among the 555 patients, 501 (90.3%) were biologic-naïve (i.e., had not previously received biologic therapy). In the study, patients were divided into three treatment groups: Cosentyx 150 mg subcutaneous injection with a loading dose (induction: 150 mg subcutaneously once weekly for 4 weeks; maintenance: 150 mg once monthly), Cosentyx 150 mg subcutaneous injection without a loading dose (150 mg subcutaneously once monthly), and placebo (induction: subcutaneous injection once weekly for 4 weeks; maintenance: once monthly). The primary endpoint was the proportion of TNF-inhibitor-naïve patients treated with Cosentyx 150 mg who achieved ASAS40 response at Weeks 16 and 52. Secondary endpoints included changes over time in BASDAI and CRP (ASDAS-CRP) relative to the Ankylosing Spondylitis Disease Activity Score.

The results showed that at Week 16 of treatment, the study met the primary endpoint of ASAS40: compared with patients treated with placebo, patients treated with Cosentyx 150 mg demonstrated a statistically and clinically significant reduction in disease activity (ASAS40 response rate: 42.2% vs. 29.2%, p < 0.05). Statistically significant improvements were also observed in secondary endpoints, including pain, mobility, and health-related quality of life. The trial demonstrated consistency with previousClinical TrialConsistent durable response and safety. No new safety signals were detected.

In late April this year, Cosentyx® (Cosentyx) was approved by China’s National Medical Products Administration (NMPA) for adult patients with ankylosing spondylitis (AS) who have had an inadequate response to conventional therapy. This marks the second indication for Cosentyx® in China, following its initial approval in March 2019 for the treatment of moderate-to-severe plaque psoriasis (PsO), and it is currently the first and only interleukin inhibitor approved in China for the treatment of ankylosing spondylitis (AS).

Recently, Cosentyx® (Secukinumab) Sensoready® Pen was approved in China. As an upgraded version of the Cosentyx® pre-filled syringe, the Cosentyx® Sensoready® Pen comprehensively optimizes the original administration method. Its "one-touch" operation reduces injection difficulty and enhances patient treatment experience, while effectively preventing medication waste caused by operational errors. This brings a more convenient, safe, and efficient new treatment experience to the vast number of patients with moderate-to-severe plaque psoriasis and ankylosing spondylitis in China.

Axial spondyloarthritis (axSpA) is a spectrum of chronic inflammatory diseases characterized by chronic inflammatory back pain. The axSpA disease spectrum includes ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA); the former exhibits joint damage visible on X-rays, whereas the latter does not show such damage on X-rays. Both AS and nr-axSpA present with similar symptom burdens, including nocturnal pain, fatigue, morning stiffness, and functional disability. If left untreated, axSpA can impair physical activity, lead to work time loss, and significantly impact quality of life.

Cosentyx is the first fully human monoclonal antibody drug that specifically targets and inhibits interleukin-17A (IL-17A). It can selectively block the activity of circulating IL-17A, reduce immune system activity, and improve disease symptoms. Studies have revealed that IL-17A drives the body in variousAutoimmunityplays a crucial role in the immune response of inflammatory diseases, including psoriatic arthritis (PsA), plaque psoriasis (PsO), ankylosing spondylitis (AS), and non-radiographic axial spondyloarthritis (nr-axSpA).

Cosentyx was approved for marketing in January 2015 and has currently been approved for four indications (PsO, PsA, AS, nr-axSpA). Cosentyx has up to 5 years of continuous efficacy and safety data for the top three indications, with more than 340,000 patients worldwide having received treatment with this drug. (Bioon.com)

Original Source: Novartis Cosentyx® receivesFDA approval for new indication to treat active non-radiographic axial spondyloarthritis