New anti-inflammatory drugs! Novartis cosentix (kesantang) us label update, into the ankylosing spondylitis (as) flexible drug delivery program!
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Last Update: 2020-02-06
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Source: Internet
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Author: User
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February 6, 2020 / BIOON/ --Novartis recently announced that the U.S Food and Drug Administration (FDA) has approved the label update of the anti-inflammatory drug cosentix (Chinese trade name: kesantang, common name: secukinumab, scuchiumab, commonly known as "sujinmab") For adult patients with active ankylosing spondylitis (as), 300 mg dose of up titration is included This approval will provide more options for clinicians to provide treatment plans for patients according to clinical reactions According to the updated drug label information, when it is used to treat as patients, cosentyx (with or without load dose [loading Dosage]) through subcutaneous injection, the recommended dose is: (1) when the load dose is set, 150mg dose is given at 0, 1, 2, 3, 4 weeks and every 4 weeks after; (2) when the load dose is not set, 150mg dose is given at 4 weeks; (3) when the patient continues to present active as, consider adjusting to 300mg dose at 4 weeks This tag update is based on data from the measure 3 study This is a three-year study to evaluate the efficacy and safety of two doses of cosentyx (150mg and 300mg) in patients with as The data showed that the two doses all reached the main efficacy end point of improving as symptoms and signs Long term data showed that the response rate was higher in the 300mg group compared to the recommended 150mg dose, especially in patients who had previously received anti TNF treatment Safety is consistent with previous studies Todd fox, global head of immunology, Hepatology and dermatology for Novartis medical affairs, said: "this approval provides clinicians with flexibility to ensure that patients are able to respond best to treatment and are fully relieved from the symptoms and signs of as It's encouraging news that we're trying to reimagine medicine in the axspa disease spectrum " Axial spondyloarthroarthritis (axspa) is a long-term inflammatory disease spectrum characterized by chronic inflammatory back pain The disease spectrum of axspa includes ankylosing spondylitis (as) and radiographically negative axial spondylitis (NR axspa) The former can see joint injury under X-ray, while the latter can't see joint injury under X-ray Both as and NR axspa have similar symptom burden, including night pain, fatigue, morning stiffness and functional disability If not treated, axspa can damage activity, cause a loss of working hours, and have a significant impact on quality of life At the end of 2019, Novartis has submitted a new indication application for cosentix treatment of NR axspa to the US FDA and the European Drug Administration (EMA), potentially providing patients with a treatment plan to solve the whole disease spectrum of axspa If approved, this would be the fourth indication for cosentyx Cosentix is the first all human monoclonal antibody drug specifically targeting to inhibit IL-17A It can selectively target to block the activity of circulating IL-17A, reduce the activity of the immune system and improve the symptoms of the disease It is revealed that IL-17A plays an important role in the immune response of various autoimmune diseases, including psoriatic arthritis (PSA), plaque psoriasis (PSO), ankylosing spondylitis (as) Cosentix was approved to be on the market in January 2015, and has been approved for three indications (PSO, PSA, as) Cosentix has five years of continuous efficacy and safety data in three major indications, and more than 300000 patients worldwide have been treated with the drug In China, cosentyx (trade name: kesantang) was approved on April 1, 2019 for the treatment of adult patients with moderate to severe plaque psoriasis in line with systemic therapy or phototherapy indications It is worth mentioning that cosentyx is also the first approved psoriasis biological preparation in the list of the first batch of clinically urgent overseas new drugs released by the drug review center of the State Drug Administration in 2018 On May 20, 2019, Novartis Pharmaceutical (China) announced that cosentyx (kesenting) officially began to supply in China, bringing a new treatment scheme for the majority of Chinese patients with moderate and severe psoriasis According to the 2019 annual performance report recently released by Novartis, global sales of cosentix reached USD 3.551 billion in 2019, an increase of 28% over 2018 Cosentyx is one of the key products to drive the future growth of Novartis With the steady increase of indications, the sales volume of the drug is expected to grow steadily in the next few years Evaluatepharma, a pharmaceutical market research firm, had previously predicted that cosentix's global sales would exceed $5.5 billion in 2024 Source: Novartis cosentix ® builds on its axspa leadership with us label update for doing flexibility in ankylosing splitylitis
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