Johnson & Johnson has reinforced a key plank of its plan to build nipocalimab into a $5 billion medicine, reporting that the benefits seen earlier in a phase 3 autoimmune trial persisted through Week 60 of the open-label extension.
The FDA is reviewing a request for approval of FcRn blocker nipocalimab in generalized myasthenia gravis (gMG). J&J is late to the party, with argenx and UCB already selling rival FcRn blockers, but has bet big in the belief nipocalimab has advantages over the competition. Ongoing dosing with argenx’s Vyvgart and UCB’s Rystiggo is based on clinical evaluation. J&J has studied consistent dosing of nipocalimab.
The Big Pharma previously reported a 5.73-point reduction on a gMG symptom scale after 24 weeks of the open-label extension. The reduction hit 5.97 points at Week 48. Tuesday, J&J published the latest cut of data from the ongoing extension trial, reporting a reduction of 5.64 points after 60 weeks.
The average symptom score fell 6.01 points in people who switched to nipocalimab from placebo after the trial’s double-blind period. Forty-five percent of antibody-positive patients reduced or discontinued steroids. The mean dose of the steroid prednisone decreased from 23 mg to 10 mg a day.
If the FDA approves nipocalimab, the long-term data could form part of J&J’s pitch for the gMG market. The labels for argenx’s Vyvgart, in its intravenous and subcutaneous forms, state the safety of delivering ongoing doses less than 50 days apart hasn’t been established. The figure for UCB’s Rystiggo is 63 days.
J&J, which acquired nipocalimab in its $6.5 billion takeover of Momenta Pharmaceuticals, has made the case that its FcRn blocker should be safer than rival molecules because it is highly specific to the IgG binding site without overlap on the albumin binding site. Consistent nipocalimab dosing could support sustained disease control, strengthening J&J’s play for the gMG market and other indications.
However, the company will face a well-established rival in gMG. Argenx won approval in 2021 and later launched a subcutaneous version. The biotech has pointed to the established safety profile of Vyvgart as a factor that could help it hold off competition.