Imaavy now approved in UK as treatment option for generalized MG
Infusion therapy aims to ease symptoms, restore daily function for patients
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- The U.K.'s regulatory agency has approved the Johnson & Johnson therapy Imaavy to treat generalized myasthenia gravis in people ages 12 and older.
- The infusion treatment is designed to ease symptoms and reduce disease severity by targeting self-reactive antibodies.
- Imaavy was approved in the U.S. and the EU last year, also for adults and adolescents with gMG.
The infusion therapy Imaavy (nipocalimab) is now approved in the U.K. for treating people ages 12 and older with generalized myasthenia gravis (MG).
The new authorization by the Medicines and Healthcare Products Regulatory Agency (MHRA), the body that regulates the use of medications in Great Britain, allows the Johnson & Johnson therapy to be used for easing MG symptoms and reducing overall disease severity among people with the autoimmune neuromuscular disorder.
“Myasthenia gravis can significantly affect a person’s ability to carry out everyday activities, and [this] authorisation provides an additional treatment option for adults and adolescents living with this condition,” Julian Beach, MHRA’s executive director of healthcare quality and access, said in a U.K. government press release announcing the decision.
Imaavy was approved last year in the U.S. and the European Union for the treatment of adults and adolescents with generalized MG who test positive for self-reactive antibodies against the acetylcholine receptor (AChR) or muscle-specific kinase (MuSK) proteins, the two most common types of MG-causing antibodies. The treatment was shown in clinical trials to help participants with MG regain daily functions like chewing, swallowing, speaking, and breathing.
Myasthenia gravis (MG) occurs when self-reactive antibodies of the immunoglobulin G (IgG) type mistakenly attack proteins, such as AChR and MuSK, involved in the communication between nerves and muscles. As a result, patients experience muscle weakness and fatigue. In gMG, the disease affects muscles throughout the body.
Given as a slow infusion into a vein (intravenously) every two weeks, Imaavy contains nipocalimab, an antibody that binds to and blocks a protein known as the neonatal Fc receptor (FcRn). This protein normally protects circulating IgG antibodies from destruction.
By suppressing FcRn, Imaavy reduces the amount of self-reactive IgG antibodies in the bloodstream, which is expected to improve nerve-to-muscle communication and ease MG symptoms.
Imaavy approval based on positive clinical trial results
Imaavy was approved based on data from more than 150 adults with generalized MG who participated in the placebo-controlled Phase 3 VIVACITY-MG3 clinical trial (NCT04951622), and eight adolescents with gMG who took part in the Phase 2/3 VIBRANCE-MG study (NCT05265273).
We have assessed the evidence for [Imaavy] and are satisfied it meets our standards for safety, quality and effectiveness.
VIVACITY-MG3’s results showed that Imaavy, when added to standard care, significantly reduced blood levels of MG-driving antibodies and the impact of the disease on daily activities, compared with a placebo. Similar benefits were seen in adolescents, even though VIBRANCE-MG did not include a placebo group.
The most common side effects include increased levels of cholesterol and other fatty molecules in the blood, and lower levels of albumin, a protein that helps maintain fluids in balance in the body. Muscle spasms and swelling of the hands, ankles, or feet also were among the most common side effects of treatment.
“We have assessed the evidence for [Imaavy] and are satisfied it meets our standards for safety, quality and effectiveness,” Beach said. “As with all authorised medicines, we will continue to monitor its safety closely.”
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