FDA Approved TG Therapeutics' Multiple Sclerosis Drug

The TG Therapeutics’ drug, Bruimvi, is the first of its kind, and is expected to become available in early 2023.

Key takeaways:
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    The FDA just approved a drug made by TG Therapeutics Inc. for people with relapsing multiple sclerosis.
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    Called Briumvi, the drug is the first monoclonal antibody of its kind that can be taken in one-hour infusions, twice a year.
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    MS is the most common disease of the central nervous system in young adults, affecting nearly one million Americans over the age of 18.

The Food and Drug Administration (FDA) approved TG Therapeutics Inc's drug for relapsing multiple sclerosis patients on Wednesday.

TG Therapeutics drug, Briumvi, is the first and only monoclonal antibody approved for patients with relapsing forms of multiple sclerosis.

“Today’s FDA approval marks an exciting day for everyone touched by MS and everyone that has worked on the development of Briumvi. We believe in the importance of treatment alternatives for patients and believe the profile of Briumvi offers unique attributes to patients and physicians alike," Lawrence Steinman, MD, Professor of Neurology Neurological Sciences, and Pediatrics at Stanford University, said in a statement.

Briumvi can treat adult MS patients with clinically isolated syndrome (CIS), relapsing-remitting disease (RIS), and active secondary progressive disease. Once available, people can take Briumvi in a one-hour infusion twice a year, after an initial dose.

In recent studies, Briumvi showed significant signs of reducing the annual relapse rate for MS. Research published in the New England Journal of Medicine also showed the drug could reduce the number of T1 Gd-enhancing lesions, which show signs of active disease and are critical for in-patient MS checks.

MS is the most common disease of the central nervous system in young adults.

The disease affects the brain and spinal cord and often causes problems with a person's vision, balance, mobility, and other body functions.

Doctors tend to treat MS symptoms with a mix of medicines, such as anti-inflammatory drugs and steroids. But because scientists have yet to find a cure, these drugs can only help reduce or slow the effects of symptoms.

Previous MS treatments include certain forms of disease-modifying therapy (DMT). If an MRI shows a patient with clinically silent lesions, they often get DMT. This lowers the chance that the MS will get worse and turn into a complete diagnosis.

Although the data doesn't say how long treatment should last, it would make sense to talk about stopping DMT in patients with CIS who have been stable for a few years without getting any new lesions. The main goal of DMT is to prevent relapse of MS. However, DMT is not necessarily a treatment for MS relapses.

News of Briumvi is especially significant for MS patients seeking alternative treatments for relapsing multiple sclerosis.

“This approval is great news for patients living with MS and provides an appealing treatment alternative that can be administered in a one-hour infusion twice-a-year following the starting dose, which I believe is an added benefit to patients,” said Dr. Steinman.

A study funded by the National MS Society estimates that nearly one million people over 18 live with MS.

“MS is most frequently diagnosed during the prime of a person’s life when they are just starting a career or beginning a family. The availability of anti-CD20s has launched a new era of high efficacy therapies for multiple sclerosis,” said June Halper, CEO of the Consortium of Multiple Sclerosis Centers.

Briumvi is expected to be available to the U.S. in early 2023.

“We remain committed to the patients we serve and providing seamless access to Briumvi once launched,” said Michael S. Weiss, TG Therapeutics’ CEO.

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