New Subcutaneous Injection Approved for Multiple Sclerosis Treatment in Italy
A new, more convenient treatment option for multiple sclerosis (MS) has been approved by the Italian drug agency (AIFA). Ocrelizumab, now available as a ten-minute subcutaneous injection administered twice a year, offers a significant betterment for patients with relapsing forms of MS (SMR) and primary progressive MS (SMPP).
Approved by the European Commission in June 2024 based on the Ocarina II study data, the subcutaneous formulation reduces wait times for treatment initiation and eliminates the need for intravenous infusions. This new method maintains the same dosage schedule as the established intravenous infusion, which has been used to treat over 350,000 patients globally, including 14,000 in Italy, over the past 11 years.
The benefits of this new administration method were discussed at a meeting in Milan on September 10th. Experts highlighted its positive impact on patients, caregivers, and healthcare professionals.
“Administration every six months makes therapy easier and more accessible to people with multiple sclerosis,” stated Massimo Filippi, president of the college of ordinary professors of neurology, “offering significant time savings for patients, caregivers, and healthcare professionals, positively impacting the entire care pathway.”
Mario alberto Battaglia, general manager of the Italian Multiple Sclerosis Association, emphasized the improved quality of life: “This new administration method represents a concrete evolution in how people with MS can live their therapy. When a cure adapts better to everyday life, it improves adherence, and returns time, autonomy, and dignity.”
The subcutaneous treatment also benefits MS centers, allowing for optimized resource allocation, according to Claudio Gasperini, director of the neurology and neurophysiopathology unit at San Camillo-Forlanini in Rome. He noted that administering the injection directly within the clinic ensures clinical safety, continuous monitoring, and promotes treatment adherence.
Importantly, the new formulation is especially beneficial for women with MS who are planning a family. Eleonora Cocco, a professor of neurology at the University of Cagliari, described it as “an important high-effective option,” due to its prolonged immunomodulatory activity and low placental transfer risk. evidence suggests no increased risk of adverse pregnancy outcomes or negative effects on infants, even during breastfeeding. This allows women to manage their MS effectively while pursuing motherhood with greater peace of mind.
Anna Maria Porrini, medical director of Roche Italia, reaffirmed Roche’s commitment to ongoing research and advancement, stating that innovative clinical programs remain central to their ambition to expand scientific understanding of MS, reduce disability progression, and improve the therapeutic experience for those living with the disease.
