On October 6, Novartis' Secukinumab (Secukinumab, Trade Name:Cosentyx) Intravenous injection has been approved by the FDA for marketing, used to treat adult patients with psoriatic arthritis (PsA), ankylosing spondylitis (AS), and non-radiographic axial spondyloarthritis (nr-axSpA). This product is the only IL-17A monoclonal antibody intravenous injection approved for marketing, and it is alsoPsA, AS andnr-axSpAetc.A disease with a second intravenous option beyond tumor necrosis factor-alpha (TNF-α) inhibitors.
Secukinumab is an IL-17A monoclonal antibody developed by Novartis, with the initial formulation being a subcutaneous injection.SecukinumabMonoclonal AntibodySkinInjectableIt was first approved for marketing in Japan in December 2014, and subsequently approved in Europe and the United States in January 2015. This subcutaneous injection has currently been approved for five indications in the United States: 1) Moderate to severe plaque psoriasis in patients aged 6 years and older who are candidates for systemic therapy or phototherapy; 2) Active PsA in patients aged 2 years and older; 3) Adult active AS; 4) Adult active with objective signs of inflammation.nr-axSpA; 5) Active enthesitis-related arthritis (ERA) in patients aged 4 years and above.
Secukinumab Instructions
(Source: FDA official website, Version: 2023/7/24)
University of WashingtonClinical Professor at the Medical College and Swedish Medical CenterPhilip J. Mease, MD, Director of Rheumatology Research, said:"There are millions of patients with PsA, AS, and nr-axSpA in the United States, a significant portion of whom require treatment through intravenous infusion for various reasons, including dissatisfaction with self-injection or simply a preference for receiving treatment at healthcare facilities. The approval of Cosentyx's intravenous formulation is an important milestone for patients, as it will expand their treatment options, allowing them to...Based onExistingDosage Form (Referring to Secukinumab Subcutaneous Injection)ComfortSex and Familiarity"Choose a mechanism of action different from existing biologic intravenous agents."Vice President of Novartis US and Head of ImmunologyChristy SiegelSay:"At Novartis, we are committed to ensuring that healthcare providers and patients have access to treatment options that meet their unique needs. With the approval of Cosentyx as both an intravenous and subcutaneous injection, we can expand the use of Cosentyx, helping more patients manage their condition with a drug validated by over a decade of clinical research and eight years of real-world evidence."Currently, four IL-17A monoclonal antibodies have been approved for marketing globally, respectively.Netakimab (Biocad/Shanghai Pharma Biokang), Ixekizumab (Eli Lilly), Bimekizumab (UCB), and Secukinumab (Novartis), among which only Secukinumab is approved for both intravenous and subcutaneous injection.Copyright © 2023 PHARMCUBE. All Rights Reserved.
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