Novartis Secures FDA Label Update for Cosentyx® in Ankylosing Spondylitis, Introducing Flexible 300mg Dosing Option

February 06, 2020 / Bioon -- Novartis recently announced that the U.S. Food and Drug Administration (FDA) has approved a label update for the anti-inflammatory drug Cosentyx (Chinese brand name: Kesenting; generic name: secukinumab), incorporating a 300 mg up-titration option for adult patients with active ankylosing spondylitis (AS). This approval will provide clinicians with more treatment options, allowing them to tailor therapeutic regimens based on clinical response.

Based on the updated drug labeling information, for the treatment of patients with ankylosing spondylitis (AS), Cosentyx (with or without a loading dose) is administered via subcutaneous injection at the recommended dosages as follows: (1) When a loading dose is used, administer 150 mg at Weeks 0, 1, 2, 3, and 4, followed by 150 mg every 4 weeks thereafter; (2) When no loading dose is used, administer 150 mg every 4 weeks; (3) If patients continue to exhibit active AS, consider adjusting the dosage to 300 mg every 4 weeks.

This label update is based on data from the MEASURE 3 study. This three-year study evaluated the efficacy and safety of two doses of Cosentyx (150 mg and 300 mg) in patients with ankylosing spondylitis (AS). The data showed that both doses met the primary efficacy endpoint of improving signs and symptoms of AS. Long-term data demonstrated higher response rates with the 300 mg dose compared to the recommended 150 mg dose, particularly in patients who had previously received anti-TNF therapy. The safety profile was consistent with previous studies.

Todd Fox, Global Head of Medical Affairs for Immunology, Hepatology, and Dermatology at Novartis, stated, “This approval adds flexibility for clinicians to ensure patients can achieve the best possible response to treatment and attain complete remission from the signs and symptoms of AS. This is encouraging news as we strive to reimagine the medical landscape across the axSpA disease spectrum.”

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 are associated with 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.

By the end of 2019, Novartis had submitted applications to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for a new indication of Cosentyx in the treatment of nr-axSpA, potentially providing patients with a therapeutic option addressing the entire disease spectrum of axSpA.If approved, this will be the fourth indication for Cosentyx.

Cosentyx is the first fully human monoclonal antibody drug that specifically targets and inhibits interleukin-17A (IL-17A). It selectively blocks the activity of circulating IL-17A, reduces immune system activity, and alleviates disease symptoms. Studies have revealed that IL-17A plays a critical role in driving immune responses in various autoimmune 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). Cosentyx has up to 5 years of continuous efficacy and safety data across these three indications, with more than 300,000 patients worldwide having received treatment with this drug.

In China, Cosentyx (brand name: 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 among those listed in the “First Batch of Overseas New Drugs Urgently Needed for Clinical Use,” released by the Center for Drug Evaluation of the National Medical Products Administration in 2018. On May 20, 2019, Novartis Pharmaceuticals (China) announced the official launch of nationwide supply of Cosentyx (Cosentyx), providing a novel treatment option for Chinese patients with moderate-to-severe psoriasis.

According to Novartis’s recently released 2019 annual performance report, global sales of Cosentyx reached $3.551 billion in 2019, representing a 28% increase from 2018. As one of the key products driving Novartis’s future growth, Cosentyx is expected to see steady sales growth in the coming years with the continuous expansion of its indications. Pharmaceutical market research firm EvaluatePharma had previously predicted that global sales of Cosentyx would exceed $5.5 billion by 2024. (Bioon.com)

Original Source: Novartis Cosentyx® builds on its axSpA leadership with US label update for dosing flexibility in ankylosing spondylitis