FDA Approves New MS Treatment
The Food and Drug Administration (FDA) has approved a new treatment for adult patients with relapsing forms of multiple sclerosis (MS). The Dec. 28, 2022 announcement states that TG Therapeutics, Inc. has been authorized to manufacture the injectable medication Briumvi (ublituximab-xiiy).
MS is a potentially debilitating autoimmune disease of the brain and spinal cord. Patients with the disease have an immune system that attacks the protective myelin sheath that covers nerve fibers, disrupting communication between the brain and the rest of the body. Over time, damage from MS can cause permanent nerve damage. Depending on the severity of symptoms, patients with MS may suffer temporary symptoms with long periods of remission or lose the ability to move their limbs permanently.
While there is no cure for MS, there are a variety of treatments that can help patients recover from spikes in symptoms and lessen the damage over time. Briumvi is an injectable medication designed to increase the time between MS episodes.
In clinical trials, Briumvi was compared to the medicine teriflunomide in a double-blind, randomized setting for 96 weeks. These studies analyzed whether Briumvi would lower the annualized relapse rate (ARR) of patients. According to the FDA, in both studies: “Briumvi significantly lowered the ARR compared to teriflunomide.” Some side effects that were observed in these clinical trials include:
- Elevated heart rate
- Influenza-like illness
- Throat irritation
Additionally, some patients experienced serious bacterial, fungal, or viral infections during the clinical trial.
Executive Vice President of Advocacy & Healthcare Access at the National MS Society Bari Talente commented on the FDA’s approval of Briumvi, stating: “We are pleased there is a new high-efficacy treatment option approved for relapsing MS. For a complex disease like MS, having additional treatment options for people to consider is incredibly important.”
Talente also went on to praise the manufacturer TG Therapeutics for pricing Briumvi “significantly lower” than other available multiple sclerosis treatments. According to Talente, this choice helps to increase access to treatment and allows more people to benefit from this therapy.