Johnson & Johnson has taken another step toward realizing a return on its $6.5 billion nipocalimab bet, filing for FDA approval to challenge argenx and UCB for the generalized myasthenia gravis (gMG) market.
J&J acquired the FcRn blocker in its takeover of Momenta Pharmaceuticals in 2020. The drugmaker sees nipocalimab as a candidate that can generate peak sales in excess of $5 billion, despite argenx and UCB beating it to market. Argenx won approval for Vyvgart in 2021. UCB secured authorization for Rystiggo in 2023. All the companies are working to establish their products in multiple indications.
With J&J disclosing its first filing for FDA approval of nipocalimab on Thursday, the Big Pharma is set to cede a multi-year head start to its rivals. J&J sees points of difference that could help nipocalimab come from behind in gMG and establish a strong position in other indications.
In gMG, the company is pitching nipocalimab as the only FcRn blocker “to demonstrate sustained disease control measured by improvement in [the gMG symptom scale] MG-ADL when added to background [standard of care] compared with placebo plus SOC over a period of six months of consistent dosing.” J&J also enrolled a broader population, although Vyvgart and Rystiggo still cover most people with gMG.
Asked about nipocalimab on an earnings call in July, Iris Löw-Friedrich, chief medical officer at UCB, made the case that Rystiggo stands apart from the competition. Löw-Friedrich said UCB is the only company to “have really demonstrated that we have a positive impact on all dimensions of fatigue.” That matters, the executive said, because fatigue is the most bothersome symptom for patients with gMG.
The jostling for position could continue for years as the three companies’ FcRn products go toe to toe in multiple indications. Argenx, which generated $478 million in net product sales in the second quarter, is seeking to capitalize on its first-mover advantage in gMG and chronic inflammatory demyelinating polyneuropathy while UCB and J&J work to win share and carve out their own niches.