IMAAVY, a monoclonal antibody developed by J&J used to treat generalised myasthenia gravis (gMG), received FDA approval. This drug is the first and only FcRn blocker approved for treating gMG, a rare chronic autoimmune disorder that causes muscle weakness.
This drug offers a new treatment option in a proven class with the potential for lasting disease control in the broadest population set of patients living with gMG. Adults and paediatric patients aged 12 and above who are anti-acetylcholine receptor (AChR) or anti-muscle-specific kinase (MuSK) antibody positive are eligible for this treatment.
IMAAVY functions as an immunoselective therapy that significantly reduces immunoglobulin G (IgG), including harmful IgG autoantibodies, without additional detectable effects on other adaptive and innate immune functions.
Data from the ongoing Vivacity-MG3 study supported this approval. The study showed that IMAAVY plus standard of care resulted in disease control throughout 24 weeks when compared to placebo plus SOC, as measured by improvement in the MG-ADL score. This score assesses the impact of gMG on a patient’s daily functions, including chewing, swallowing, and speaking.
Furthermore, IMAAVY demonstrated a rapid and sustained reduction in autoantibody levels by up to 75% from the first dose and during 24 weeks of monitoring. Dr Nichloas J. Silvestri, M.D., Professor of Neurology at University of Buffalo said: “Having a treatment that delivers this level of durable symptom stability is a meaningful step forward for managing a complex and unpredictable disease like gMG.”
This announcement is a critical turning point for patients with gMG. David Lee, M.D., Ph.D., Global Immunology Therapeutic Area Head, Johnson & Johnson Innovative Medicine, echoed these sentiments: “Today’s FDA approval of IMAAVY marks a historic milestone for the more than 240 million patients suffering with autoantibody diseases, many with few or no approved targeted treatments.”
