The FDA nod of J&J autoimmune drugs may be the possibility of a large piece of product.
Johnson & Johnson Autoimmune Disease Medicine is now a relatively late-stage drug in its drug category and can now compete with the first label of a wider patient population with the products available to Argenx and UCB.
The FDA has approved the J&J drug, known in development as Nipocalimab, as a myocardium therapy (GMG) for generalized myocardium weakness. The regulatory decision announced Wednesday could be the first of several types of the antibody, which is expected to reach a peak sales of $5 billion. The new J&J products are sold as intravenous infusion every two weeks and are sold under the brand Imaavy.
In GMG, autoantibodies produced by the immune system attack proteins associated with communication between nerves and muscles. The patient will experience severe muscle weakness and speech and swallowing problems. J&J said an estimated 100,000 people live in GMG. There are about 700,000 patients worldwide.
Imaavy utilizes the built-in mechanisms of cells to manage proteins, including antibodies. Proteins usually bring them into cells, and they either enter the cellular system that degrades them or are recycled into circulation. Antibodies that bind to neonatal FC receptor (FCRN) are recovered. The antibodies in Imaavy are designed to block FCRN, a method that aims to increase the degradation of the autoantibodies of the disease. GMG approval covers adults and children over the age of 12 who are positive for ACHR or MUSK autoantibodies that drive the disease.
In a Phase 3 test in adults, J&J reported that imaavy reduced autoantibodies levels by up to 75% from the first dose. This reduction continued throughout the 24-week study. The results were published in Lancet Neurology in February.
Dr. Nicholas Silvestri, professor of neurology at the University of Buffalo, announced in the approval announced by J&J. “Having a treatment that provides stability of this durable symptom is to manage complex and unpredictable diseases like GMG and have additional FCRN treatments in both ACHR+ and Musk+ adult and pediatric patients, bringing additional FCRN treatment to a wider range of patients.”
In the 2/3 phase test of pediatric patients, J&J reported a 69% reduction in disease-driven autoantibodies within 24 weeks. The ability to treat pediatric GMG patients distinguishes Imaavy from competitors.
Argenx’s Vyvgart, which was approved by FDA in 2021, is the first FCRN blocking drug to attract GMG patients. This antibody fragment only solves diseases driven by ACHR autoantibodies. The agency signed a subcutaneous injection version of the drug Vyvgart Hytrulo in 2023. Both products are only for adults.
UCB promotes a FDA-approved FCRN blocker Rystiggo, which has been infused weekly, addressing both ACHR and MUSK antibodies. The Belgian company also has another FDA-approved GMG drug Zilbrysq. The drug blocks a complement system protein that drives the disease, and its approval in GMG covers only patients with ACHR antibody positive. The 2023 approval of both UCB products is only allowed in adults.
Imaavy is the main asset of Momensa Pharmaceuticals, which J&J acquired in 2020 for $6.5 billion. Momensa is developing multiple autoimmune-indicated antibodies, and J&J is continuing the strategy. According to investors, in addition to rare autoantibodies, J&J has developed this drug for pregnancy-to-antibody diseases as well as common rheumatoid diseases such as lupus and rheumatoid arthritis. The company is currently planning 10 indications for the drug.
J&J’s Imaavy’s $5 billion peak sales projection covers all potential signs. However, if the product successfully expands its approved uses, it may also conflict with FCRN block drugs from Argenx and UCB. Both companies are conducting clinical studies that can support the expansion of their respective products to other indications. Last summer, the FDA approved Argenx’s Vyvgart Hytrulo as a new approach to chronic inflammatory demyelinated polyneuropathy (CIDP). This rare disease in which autoantibodies attack nerves is one of the signs that J&J is pursuing with Imaavy.
Photos of Johnson & Johnson
