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Anvisa has approved the registration of Briumvi (ublituximab), a new treatment for multiple sclerosis that acts on B lymphocytes to reduce relapses in adults with recurrent forms of the disease, which affects 40,000 Brazilians and 2.9 million people worldwide with no known cure.
Anvisa (National Health Surveillance Agency) has approved a new treatment for multiple sclerosis, expanding the therapeutic options available for the approximately 40,000 Brazilians living with the disease. The drug Briumvi (ublituximab), from the pharmaceutical company Neuraxpharm, had its registration published in the Official Gazette of the Union on April 22nd, and is a monoclonal antibody indicated for adults diagnosed with recurrent forms of multiple sclerosis, a condition in which symptoms manifest in periodic relapses that progressively compromise the patient’s neurological capacity. The validity of the registration granted by Anvisa extends until 2036.
The mechanism of action of the new drug against multiple sclerosis is targeted and specific. Ublituximab acts on a protein called CD20, present on the surface of B lymphocytes, immune system cells that play a central role in the progression of the disease. By decreasing the activity of these cells, the drug helps to contain the inflammatory processes that attack the central nervous system, reducing the frequency and intensity of crisis episodes. For patients with multiple sclerosis, fewer relapses mean less accumulation of neurological damage over time, a benefit that can translate into greater preservation of motor and cognitive functions.
What is multiple sclerosis and why is this medication relevant
Multiple sclerosis is a chronic autoimmune and inflammatory disease in which the body’s own defense system attacks myelin, the protective layer that surrounds neurons and allows the transmission of signals between the brain and other parts of the body. When this covering is destroyed by the action of dysregulated lymphocytes, neuronal communication deteriorates, and patients with multiple sclerosis begin to experience symptoms that include severe fatigue, limb weakness, loss of balance, chronic pain, changes in reasoning ability, and problems with urinary control. The disease has no known cure, and the goal of all available treatments is to slow progression and control inflammatory episodes.
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The arrival of ublituximab in Brazil represents a significant addition to the therapeutic arsenal. Although other monoclonal antibodies are already approved for multiple sclerosis, each new drug entering the market offers an alternative for patients who do not respond adequately to previous therapies or who experience side effects that limit continuous use. The diversification of options is fundamental in a chronic disease that requires treatment for decades, as individual responses vary, and what works for one patient may not work for another.
How many people are affected by multiple sclerosis in Brazil and worldwide
The numbers reveal the size of the population that can benefit from the new treatment. Approximately 2.9 million people live with multiple sclerosis globally, and in Brazil, the estimate is around 40,000 diagnosed patients, a number that tends to grow as diagnostic methods become more accessible and sensitive. The disease is more frequent in young adults between 20 and 50 years old and affects women in a higher proportion than men, a demographic profile that means decades of treatment ahead for each diagnosed person.
Early diagnosis and access to effective therapies are the two factors that most influence the prognosis of those diagnosed with multiple sclerosis. Patients who start treatment in the early stages of the disease and maintain regular follow-up can preserve functionality for longer than those who delay accessing appropriate medications. Anvisa’s approval of Briumvi does not automatically guarantee that the 40,000 Brazilians with multiple sclerosis will have immediate access to the drug, as its incorporation into the SUS (Brazil’s public health system) depends on evaluation by Conitec and eventual inclusion in the clinical protocol, a process that can take months or years.
How ublituximab differs from other multiple sclerosis treatments
The mechanism of action centered on the CD20 protein of B lymphocytes is not exclusive to ublituximab, but each drug in this class presents differences in formulation, dosage, and adverse effect profile. Briumvi enters the Brazilian market as an additional option within a group that includes other anti-CD20 antibodies, and competition among similar drugs can benefit multiple sclerosis patients both through the possibility of therapeutic adjustment and competitive pressure on prices. The availability of multiple alternatives allows neurologists to personalize treatment according to each patient’s individual response and tolerance.
The approval also occurs at a time of regulatory expansion by Anvisa. The registration of Briumvi is part of a package of updates that included other biological products and advanced therapies, signaling that the agency is processing submissions of innovative medicines at an accelerated pace. For the multiple sclerosis patient community, each new approval represents concrete hope that science is advancing towards increasingly effective treatments, even if the definitive cure for the disease remains a distant goal.
What changes in practice for those living with multiple sclerosis in Brazil
The approval of the drug by Anvisa is the first step on a path that includes pricing, distribution, and eventual coverage by health plans or incorporation into the public system. For the 40,000 Brazilians with multiple sclerosis, the existence of another therapeutic option in the national market is positive regardless of the access period, because it signals that the country is following global evolution in disease treatment and that Brazilian patients will not need to depend exclusively on imports to access latest-generation therapies.
Ublituximab does not cure multiple sclerosis, and no currently available drug does. What it offers is the possibility of controlling the B lymphocytes that cause the inflammatory outbreaks destroying the myelin of neurons, slowing the progression of a disease that, without treatment, can lead to severe motor and cognitive limitations over the years. For someone diagnosed with multiple sclerosis at 25 or 30 years old and who knows they will live with the condition for the rest of their life, having one more tool in the arsenal makes a difference that goes far beyond a line in the Official Gazette.
And you, do you know anyone living with multiple sclerosis? Do you think Brazil should accelerate the incorporation of new treatments into the SUS? Leave your opinion in the comments.
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