Roche Introduces New Treatment for Relapsing Multiple Sclerosis

The European Commission granted Roche marketing authorization for the Ocrevus (ocrelizumab) subcutaneous injection, offering a new treatment option for relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). This new formulation maintains the same twice-yearly schedule as the previously approved intravenous infusion, but allows for a faster 10-minute administration.

“Ocrevus transformed the way multiple sclerosis is treated as the first anti-CD20 therapy approved for this disease. Now, people in the European Union with multiple sclerosis can have their medicine administered in just 10 minutes twice per year without needing an IV facility. This makes it easier for more people with multiple sclerosis to access their treatment while also saving time for providers,” says Levi Garraway, Chief Medical Officer and Head of Global Product Development, Roche. 

The approval is based on data from the Phase III OCARINA II trial, which demonstrated that the subcutaneous administration achieves non-inferior levels of Ocrevus in the blood compared to the IV formulation, as reported by Roche.  The trial also confirmed a comparable safety and efficacy profile between the two methods for both RMS and PPMS patients. More than 92% of patients reported satisfaction with the subcutaneous administration, highlighting the convenience and acceptability of the new method.

The new subcutaneous injection method was developed to offer an alternative to the IV infusion, addressing the needs of both patients and healthcare professionals. The subcutaneous  injection can be administered by healthcare professionals either in a clinical setting or in other locations, providing flexibility and potentially increasing accessibility to the treatment.

Ocrevus, a humanized monoclonal antibody, targets CD20-positive B cells, which are believed to play a crucial role in the nerve cell damage seen in multiple sclerosis. By binding to these B cells, Ocervus aims to preserve essential immune system functions while preventing the progression of the disease. 

In MS patients, the immune system mistakenly attacks myelin, a fatty substance that allows nerve impulses to be transmitted quickly. The loss of myelin disrupts the nerves' ability to conduct electrical impulses between the brain and other parts of the body, according to Novartis. In Mexico, about 30 out of every 100,000 inhabitants are affected by MS, with a higher prevalence in women than in men, explains Gloria de Lourdes Llamosa, President, Mexctrims. 

Although the disease is common, most countries worldwide face barriers that prevent the early diagnosis of MS, according to WorldMSday. These barriers include the high cost of obtaining a diagnosis and the lack of public awareness of MS symptoms among both the general population and healthcare professionals, as reported by MBN.