Both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) will review Novartis‘ applications seeking regulatory approval of ofatumumab, an investigational B-cell therapy for the treatment of relapsing forms of multiple sclerosis (MS) in adults.
Novartis’ applications for ofatumumab — which has the potential to become a first-choice treatment for relapsing MS patients, easily self-administered using an autoinjector pen — were accepted by both the U.S. and EU regulatory agencies.
The FDA’s decision is expected by June 2020, with the EMA’s decision likely by 2021.
Ofatumumab is a fully human monoclonal antibody — a lab-made immunotherapy that can bind to specific proteins in the body — against CD20, a marker present on immune B-cells involved in MS development. The therapy works by binding to the CD20 protein in certain B-cells, leading to the cells’ depletion. This is thought to reduce inflammation in the central nervous system, comprised of the brain and spinal cord.
The key difference with Ofatumumab is that it would be a self-administered, once-monthly therapy using an autoinjector pen. The therapy under development is a 20 mg under-the-skin (subcutaneous) injection.
“We are excited that ofatumumab has the potential to be a powerful first-choice treatment option for patients and physicians looking for an impactful intervention,” Krishnan Ramanathan, head of the neuroscience global program at Novartis, said in a press release.
We are sorry that this post was not useful for you!
Let us improve this post!
Tell us how we can improve this post?