New Subcutaneous Solution for Multiple Sclerosis Treatment Approved in Italy
Italy has introduced a new therapeutic option in the battle against relapsing remitting multiple sclerosis (RMS). The Italian Medicines Agency has granted approval for the reimbursement of a subcutaneous (SC) solution of natalizumab, a drug developed by Biogen, for the treatment of RMS in individuals already receiving the intravenous administration method.
The subcutaneous injection offers a safety and effectiveness profile comparable to the intravenous (IV) formulation and reduces administration time by approximately 49%. This equates to more than an hour less for each treatment, benefiting individuals with multiple sclerosis (MS) and the healthcare facilities where the therapy is provided. Both the SC and IV forms of natalizumab should be administered every four weeks by a healthcare professional at a dose of 300 mg.
Over 15 years of real-world experience with this monoclonal antibody has generated extensive data supporting its clinical benefits and well-characterized safety profile. Natalizumab is currently the only highly effective therapy for the treatment of RMS that offers two delivery options, enabling doctors and patients to choose the method that suits their specific needs.
“Multiple sclerosis is a complex chronic neurological disease that requires personalized management, not only because the symptoms and course of the disease vary from person to person but also because the management of the disease fits into individual life paths, from which specific needs arise,” explains Francesco Vacca, National President of Aism, the Italian Multiple Sclerosis Association. “Life changes radically after the diagnosis, starting from the need to follow a therapeutic process, and this has a significant impact on quality of life, affecting the psychological, relational, social, and working spheres. For this reason, continuity of care, with appropriate settings, duration of visits, and adequate services, is crucial for effective and person-centered care.”
The approval of the new subcutaneous formulation of natalizumab is supported by data from the Deliver and Refine studies, where comparability to intravenous administration was demonstrated.
“Overall, both studies found that the safety of natalizumab administered subcutaneously is consistent with the well-established benefit-risk profile of intravenous administration, which has already been confirmed in other clinical trials and post-marketing settings,” comments Luca Massacesi, a professor in the Department of Neuroscience, drug and child health area of the University of Florence and director of neurology II of the Aou Careggi of Florence.
In addition, during the annual Congress of the European Academy of Neurology, the results of a groundbreaking direct comparison between subcutaneous and intravenous administration of natalizumab were presented. This analysis was conducted in Italy using data from the Refine study on a sample of 99 people with relapsing-remitting multiple sclerosis. The analysis demonstrated the non-inferiority of the subcutaneous administration route compared to the intravenous method.
The introduction of subcutaneous administration of natalizumab simplifies the treatment process as it no longer needs to be limited to specialized centers with infusion rooms and adequate nursing support. Additionally, in appropriate cases, this form of administration allows for a reduction or elimination of the post-infusion observation period after the administration of the first six doses of the drug.
The availability of this new subcutaneous solution for the treatment of multiple sclerosis is a significant development in improving patient experience and expanding treatment options.