J&J reveals key data on $6.5B autoimmune asset, ready to challenge argenx and UCB

Johnson & Johnson (J&J) recently shared phase 3 trial data on its drug nipocalimab for generalized myasthenia gravis (gMG) at the European Academy of Neurology 2024 Congress. The trial aimed to compare nipocalimab with existing FcRn-targeted therapies from argenx and UCB, both of which are already approved.

In 2020, J&J acquired nipocalimab through its $6.5 billion purchase of Momenta Pharmaceuticals. This year, J&J achieved its first phase 3 success with nipocalimab, hitting its primary endpoint. However, the broader implications for J&J's competitive standing remained unclear until the recent detailed presentation.

The trial included 153 gMG patients who were positive for specific antibodies. Those treated with nipocalimab alongside standard care experienced a 4.7-point improvement on the MG-ADL symptom scale over 22 to 24 weeks. In contrast, the control group saw a 3.25-point improvement. Additionally, nipocalimab was associated with a 4.86-point reduction on the QMG disease severity scale, compared to a 2.05-point decrease in the control group.

For context, UCB earned FDA approval for Rystiggo based on a study showing a 2.6-point improvement in MG-ADL versus placebo at Day 43. In a pivotal trial for Vyvgart, developed by argenx, 68% of patients achieved at least a two-point improvement in MG-ADL, compared to 30% in the placebo group.

J&J's study targeted a more diverse patient population than its competitors. While argenx’s Vyvgart is approved for individuals with anti-AChR antibodies and UCB's Rystiggo covers both anti-AChR and anti-MuSK antibodies, J&J enrolled patients with antibodies against AChR, MuSK, and LRP4. However, it's important to note that the majority of gMG patients, up to 90%, have antibodies against AChR. The subpopulation with LRP4 antibodies, included in J&J’s trial, represents up to 5% of gMG cases.

The phase 3 trial of nipocalimab used an intravenous dosing regimen, similar to Vyvgart. Argenx also offers a subcutaneous version of Vyvgart called Vyvgart Hytrulo, which has contributed significantly to its sales growth. In the first quarter, global sales for Vyvgart's intravenous and subcutaneous formulations reached $398 million. UCB's Rystiggo is also administered subcutaneously.

With these promising results, J&J plans to seek regulatory approval for nipocalimab for gMG later this year. Additionally, the company is exploring other potential indications for the drug.