Novartis Announces EU Label Update for Cosentyx Including Axial Manifestations of Psoriatic Arthritis Based on MAXIMISE Trial Data
Novartis
Drug Development and Manufacturing
European Medicines Agency
The European Medicines Agency (EMA) is a decentralized agency of the European Union (EU), located in London. It began operations in 1995. The agency is responsible for the scientific evaluation, supervision, and safety monitoring of medicines developed by pharmaceutical companies for use in the EU. By ensuring that all medicines available on the EU market are safe, effective, and of high quality, the EMA protects public and animal health in the 28 EU Member States and countries of the European Economic Area.
Committee for Medicinal Products for Human Use
Committee for Medicinal Products for Human Use (CHMP)The Committee for Medicinal Products for Human Use (CHMP) is the committee within the European Medicines Agency (EMA) responsible for human medicines. The CHMP replaced the former Committee for Proprietary Medicinal Products (CPMP) in May 2004.The CHMP plays a vital role in the authorization of medicines in the European Union (EU). In the centralized procedure, the CHMP is responsible for: 1) conducting initial assessments of marketing authorization applications across the EU; assessing modifications or extensions to existing marketing authorizations (“variations”); considering recommendations from the Agency’s Pharmacovigilance Risk Assessment Committee regarding the safety of medicines on the market, and, where necessary, advising the European Commission to amend the marketing authorization of a medicinal product, or to suspend or withdraw it from the market.The CHMP also evaluates medicines authorized at the national level that are referred to the EMA, with the aim of maintaining a harmonized position throughout the EU.Furthermore, the CHMP and its working groups promote the development of medicines and pharmaceutical regulation by: providing scientific advice to companies researching and developing new medicines; developing scientific and regulatory guidelines to assist pharmaceutical companies in preparing marketing authorization applications for human medicines; and collaborating with international partners to harmonize regulatory requirements.
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Novartis recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a final opinion approving a Class II label change for the anti-inflammatory drug Cosentyx (secukinumab), incorporating data on axial manifestations of psoriatic arthritis (PsA) from the first-in-class MAXIMISE trial. Notably, these are the first data to demonstrate the efficacy and safety of a biologic agent in managing axial manifestations of PsA.
PsA patients with axial involvement have a higher disease burden, characterized by greater pain, fatigue, morning stiffness, impaired physical function, increased enthesitis count, and elevated inflammatory markers. Furthermore, these patients report poorer quality of life and/or work productivity.
Cosentyx is the only fully human interleukin-17A (IL-17A) inhibitor whose efficacy and safety have been demonstrated in a Phase IIIb study specifically evaluating axial manifestations of psoriatic arthritis (PsA). It is the first biologic agent proven to be effective across all six key manifestations of PsA, including axial involvement, peripheral disease, enthesitis, dactylitis, cutaneous psoriasis, and nail psoriasis.
Currently, the approved indications for Cosentyx include plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis (nr-axSpA). In 2020, Cosentyx generated sales of $3.995 billion, making it Novartis’s top-selling product.
This EU label update reinforces Cosentyx’s leadership position in rheumatology and immune-mediated dermatology. Novartis plans to expand the indications for Cosentyx to 10 within the next 10 years.
MAXIMISE is a 52-week, double-blind, randomized, placebo-controlled Phase IIIb study evaluating the efficacy and safety of Cosentyx for the management of axial manifestations in psoriatic arthritis (PsA). The study enrolled a total of 498 patients with PsA who had clinician-diagnosed axial involvement, spinal pain rated as >40/100 on a visual analog scale (VAS), and a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score >4, despite treatment with at least two nonsteroidal anti-inflammatory drugs (NSAIDs). The study comprised two treatment periods: a placebo-controlled period from baseline to Week 12 (Treatment Period 1), followed by an active treatment period from Week 12 to Week 52 (Treatment Period 2). At Week 12, patients in the placebo group were re-randomized to receive subcutaneous injections of Cosentyx 300 mg or 150 mg.
In the study, patients received subcutaneous injections of Cosentyx 300 mg or 150 mg once weekly for 4 weeks, followed by dosing every 4 weeks thereafter. The primary endpoint was the proportion of patients treated with Cosentyx 300 mg who achieved a 20% improvement in Assessment of SpondyloArthritis international Society (ASAS) criteria (ASAS20 response) at Week 12. The key secondary endpoint was ASAS20 response at Week 12 in patients treated with Cosentyx 150 mg, assessed after demonstrating the superiority of Cosentyx 300 mg.
The results showed that the study met its primary and key secondary endpoints: at Week 12 of treatment, 62.9% and 66.3% of patients in the Cosentyx 300 mg and Cosentyx 150 mg groups, respectively, achieved ASAS20 response, compared with 31.3% in the placebo group. Furthermore, patients treated with Cosentyx demonstrated rapid improvement in signs and symptoms of axial manifestations of psoriatic arthritis (PsA) as early as Week 4, which was sustained through Week 52. The safety profile in this study was consistent with previous studies, with no new safety signals identified.
*Disclaimer: This article was written by an author contributing to Sina Medical News. The views expressed are solely those of the author and do not represent the position of Sina Medical News.