The approval allows Kesimpta to be used as an injection for subcutaneous use to treat RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
Kesimpta is an anti-CD20 monoclonal antibody (mAb) self-administered via a once-monthly injection, delivered subcutaneously.
According to the company, Kesimpta is the first B-cell therapy that can be self-administered once monthly at home by using the Sensoready autoinjector pen.
The approval of Kesimpta was based on data from the phase III ASCLEPIOS I and II studies, where the drug showed superiority against teriflunomide in significantly minimising the annualised relapse rate, three-month confirmed disability progression, and the number of gadolinium-enhancing (Gd+) T1 and new or enlarging T2 lesion.
The ASCLEPIOS I and II studies are twin, identical design, flexible duration (up to 30 months), double-blind, randomised, multi-centre studies are designed to assess the safety and efficacy of Kesimpta 20mg monthly subcutaneous injections against teriflunomide 14 mg oral tablets taken once daily in adults with RMS.
Both trials recruited 1,882 patients with MS, between the ages of 18 and 55 years, with an Expanded Disability Status Scale (EDSS) score between 0 and 5.5. The trials were conducted in more than 350 sites in 37 countries.
The company is planning to start the commercialisation of Kesimpta in the US in early September.
With European regulatory approval expected in the second quarter of 2021, additional regulatory filings are currently underway for Kesimpta across the world.
Novartis Pharmaceuticals president Marie-France Tschudin said: “When treating patients with RMS, Kesimpta is a meaningful treatment option that delivers both high efficacy and safety with the ability for patients to have more freedom in managing their disease.
“The development of Kesimpta is a great example of our commitment, knowledge and understanding of multiple sclerosis, which enabled us to identify a targeted treatment that can significantly improve patient outcomes and experience.”
In June, Novartis secured FDA approval for its Cosentyx (secukinumab) to treat active non-radiographic axial spondyloarthritis (nr-axSpA).