Novartis’ Cosentyx Receives Positive CHMP Opinion for Treatment of Non-Radiographic Axial Spondyloarthritis (nr-axSpA)

March 28, 2020 /BioonBIOON/ --NovartisNovartis recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion, recommending the approval of the anti-inflammatory drug Cosentyx (Chinese brand name: Kesenting; generic name: secukinumab; commonly known as "Su Jin Dan Kang") for the treatment of adult patients with active radiographic-negative axial spondyloarthritis (nr-axSpA). The CHMP’s opinion will now be submitted to the European Commission (EC) for review, which is expected to make a final decision within the next 2–3 months.

Cosentyx was approved for marketing in January 2015 and has currently been approved for three indications, including: psoriatic arthritis (PsA), plaque psoriasis (PsO), and ankylosing spondylitis (AS). If the treatment of nr-axSpA is approved, it will become the fourth indication for Cosentyx, and this drug will also be the first fully human IL-17A inhibitor used to treat nr-axSpA patients in Europe. Currently, Cosentyx’s treatment for nr-axSpA is also under review in the United States.FDAreview.

In the five major EU countries and the United States, there are approximately 1.7 million patients with nr-axSpA, a condition that forms part of the axial spondyloarthritis (axSpA) disease spectrum. In clinical studies, Cosentyx demonstrated clinically meaningful results in patients with active nr-axSpA as early as Week 3, with these benefits sustained for up to one year in treated patients. If approved, Cosentyx will provide an important therapeutic option for this condition, which currently has limited treatment alternatives.

The CHMP’s positive opinion is based on the efficacy and safety results from the Phase III PREVENT clinical study (NCT02696031). This was a randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of Cosentyx in patients with active non-radiographic axial spondyloarthritis (nr-axSpA). The study enrolled 555 patients with active nr-axSpA (age at onset <45 years, 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 maximum doses for 4 weeks prior to the study and may have had an inadequate response to no more than one prior 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 achieving ASAS40 response with Cosentyx 150 mg treatment at Weeks 16 and 52. Secondary endpoints included changes over time in BASDAI and CRP (ASDAS-CRP) scores for ankylosing spondylitis disease activity.

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 TrialsConsistent durable response and safety. No new safety signals were detected.

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 shows joint damage on X-rays, while the latter does not. Both AS and nr-axSpA share a similar symptom burden, 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 plays a role in driving the body's response in variousAutoimmunityIt plays an important role in the immune response of inflammatory diseases, including psoriatic arthritis (PsA), plaque psoriasis (PsO), and ankylosing spondylitis (AS).

Cosentyx was approved for marketing in January 2015 and has currently been approved for three indications (PsO, PsA, AS). If the treatment of nr-axSpA is approved, it will become the fourth indication for Cosentyx, addressing the entire disease spectrum of axSpA. Cosentyx has up to 5 years of continuous efficacy and safety data for its three major indications, with over 300,000 patients worldwide having received treatment with this drug.

In China, Cosentyx® (Cosentyx®) was approved on April 1, 2019, for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Notably, Cosentyx® (Cosentyx®) was the first biologic agent for psoriasis to be approved from the "First Batch of Overseas New Drugs in Urgent Clinical Need" list released by the Center for Drug Evaluation of the National Medical Products Administration in 2018. On May 20 this year,NovartisNovartis (China) announced the official nationwide launch of Cosentyx® (Cosentyx®), bringing a new treatment option to patients with moderate-to-severe psoriasis in China.

In 2018, global sales of Cosentyx reached $2.837 billion, representing a 37% increase from 2017. Pharmaceutical market research firm EvaluatePharma predicts that Cosentyx will become the driving force behindNovartisAs one of the key products for future growth, with a steady expansion of indications, Cosentyx’s sales are projected to grow steadily in the coming years, with global sales expected to reach $5.5 billion in 2024. (Bioon.com)

Original source:Novartis Cosentyx® gains positive CHMP opinion for new indication in the axial spondyloarthritis spectrum