J&J readies nipocalimab to compete with Vyvgart after myasthenia gravis trial success

Johnson & Johnson has released new findings from a Phase III study of nipocalimab for treating generalised myasthenia gravis (gMG). This adds significant value to their FcRn inhibitor programme. The positive outcomes could pose a competitive threat to argenx's FcRn blocker Vyvgart (efgartigimod alfa), which gained approval in 2021 for gMG patients positive for anti-AChR antibodies.

The VIVACITY-MG study results presented at the European Academy of Neurology (EAN) conference demonstrated that nipocalimab outperformed placebo in enhancing daily activities for gMG patients. The study involved 199 adult participants, with 153 of them being antibody-positive. Participants were either administered nipocalimab or a placebo, along with standard care. Efficacy data showed that patients treated with nipocalimab experienced a 4.70-point improvement from baseline in the Myasthenia Gravis - Activities of Daily Living (MG-ADL) score over weeks 22, 23, and 24. In contrast, those on placebo saw a 3.25-point improvement, a difference that was statistically significant.

"For someone living with gMG, a one- to two-point change on MG-ADL may be the difference between normal eating and frequent choking on food, or shortness of breath at rest and being on a ventilator," the company noted.

Secondary endpoints were also achieved, including improvements in muscle strength and function, as assessed by the Quantitative Myasthenia Gravis (QMG) score over weeks 22 and 24. Additionally, a significantly higher proportion of patients treated with nipocalimab showed a ≥2-point improvement from baseline in the MG-ADL response.

The safety profile of nipocalimab was consistent with previous studies, showing similar rates of serious adverse events and discontinuations between the nipocalimab and placebo groups.

Johnson & Johnson, which acquired nipocalimab through its $6.5-billion acquisition of Momenta Pharmaceuticals in 2020, plans to submit regulatory filings for the drug in gMG later this year. This could initiate a competitive battle with Vyvgart, a drug that generated $1.2 billion in sales in 2023.

However, Johnson & Johnson intends to differentiate nipocalimab by emphasizing its effectiveness across a broader range of antibody-positive gMG patients, including those with anti-MuSK and anti-LRP4 antibodies, in addition to the more prevalent anti-AChR antibodies. According to a recent Morgan Stanley note, a key opinion leader (KOL) sees a "sizable opportunity" for nipocalimab in gMG, potentially serving as a second-line option for patients with an incomplete response to Vyvgart. The KOL estimated that approximately 50% of Vyvgart patients might fit this profile.

The success in gMG further enriches nipocalimab's portfolio of positive clinical results in autoimmune disorders. Earlier this month, Johnson & Johnson announced that nipocalimab achieved its primary endpoint in a Phase II trial for Sjögren's disease. The drug also shows promise in treating rare maternal-foetal disorders.