Flying high after an FDA approval four months ago to treat generalized myasthenia gravis (gMG), Johnson & Johnson’s much-touted Imaavy (nipocalimab) has taken a hit, coming up short as part of a combination therapy in a rheumatoid arthritis (RA) trial.
Without revealing data from the phase 2a Daisy proof-of-concept study, J&J said that after 12 weeks, Imaavy provided no added benefit when added to an anti-TNFα therapy in patients with refractory RA.
“Based on these findings, Johnson & Johnson has decided not to proceed with the clinical development of nipocalimab in combination with an anti-TNFα therapy for RA,” the company said in its release.
Despite the setback, J&J added that it is still “confident” that Imaavy can live up to the $5 billion-plus peak sales potential the company has pegged for the FcRn-blocking monoclonal antibody.
J&J is investigating Imaavy in a host of immunology disorders, including Sjogren’s disease (SjD). Last year, the company presented data from a phase 2 study that demonstrated the effectiveness of an FcRn blocker for the first time in SjD.
The results helped earn a fourth FDA fast-track designation for Imaavy, with the others coming in gMG and two maternal fetal diseases.
J&J picked up Imaavy as the primary piece of its $6.5 billion acquisition of Momenta Pharmaceuticals in 2020.
The infused treatment isn’t the first FcRn binder on the market for gMG. Argenx got there first in 2021 with an FDA nod for its blockbuster Vyvgart. Two years later, UCB scored with its FcRn drug Rystiggo. Imaavy could become the top seller in the indication as it has the broadest label.
Imaavy works by blocking the protein FcRn, which is responsible for circulating the immunoglobulin G (IgG) antibodies that are known culprits in several autoimmune diseases. Data have shown that Imaavy is able to substantially reduce IgG levels, including IgG autoantibodies, while sparing the body’s other immune functions.