Johnson & Johnson’s (J&J) new star autoimmune drug, nipocalimab, has demonstrated its disease-modifying potential for systemic lupus erythematosus (SLE) in a late-stage trial.
During the Phase IIb JASMINE trial (NCT04882878), nipocalimab met its primary endpoint, triggering a statistically significant increase in the percentage of patients achieving SLE responder index (SRI-4) composite responses compared with placebo after 24 weeks.
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The trial also met its key secondary and exploratory endpoints, which included various measures of disease severity and activity, as well as time to first flare and treatment-emergent adverse events (TEAEs). J&J is yet to share specific data on these outcomes.
According to J&J, the results of the JASMINE trial indicate nipocalimab’s potential to spare patients from steroid use, which is often associated with poor patient quality of life (QoL) and potential organ damage when used chronically.
The neonatal Fc receptor (FcRn) blocker’s safety and tolerability profile remained consistent with other Phase II studies conducted on the drug, with no new safety signals observed.
J&J said that this makes nipocalimab the first FcRn blocker to demonstrate clinically meaningful efficacy in SLE.
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By GlobalDataFollowing the Phase II trial, J&J will advance the therapy to Phase III trials in SLE.
Nipocalimab, which is sold under the brand name Imaavy, first entered the market following its US approval in generalised myasthenia gravis (gMG). It is now being evaluated in a range of clinical-phase studies under the autoimmune umbrella – including Sjogren’s disease, thrombocytopenia and chronic inflammatory demyelinating polyneuropathy (CIDP).
SLE market set for growth
According to an epidemiology forecast from GlobalData, the parent company of Clinical Trials Arena, the diagnosed prevalence of SLE was 575,740 across the seven major markets (7MM: the US, France, Germany, Italy, Spain, the UK and Japan) in 2024.
This figure is set to grow moving forward, so there is a high need for effective, disease-modifying treatments that can both slow progression and offer symptomatic relief.
Up until 2021, the SLE market remained stagnant, with the only therapy available to patients being GSK’s Benlysta (belimumab). Since its market debut, the drug has gained approval for the treatment of adults and children five years and older with active lupus nephritis in both its original and subcutaneous formulations.
According to key opinion leaders previously interviewed by Pharmaceutical Technology, revamping formulations can help stave off losses associated with the patent cliff – though the method does have its limits.
UK-based compatriot AstraZeneca has also entered the SLE market with its type 1 interferon (IFN-1) blocker, Saphnelo (anifrolumab), gaining US and EU approval for the drug in 2021 and 2022, respectively. This follows the pharma’s choice to buy the exclusive global rights to the therapy from its maker, Medarex, in 2004.
A subcutaneous version of the therapy has shown success in SLE in a Phase III trial, providing a potentially more convenient dosing method if approved.
Now, GlobalData forecasts that Saphnelo will make $1.3bn in 2031, while Benlysta is set to bring in $2.4bn – down from its projected sales peak of $2.6bn in 2027.
If nipocalimab were to gain approval in SLE, it would have to compete with Benlysta, which has seen strong uptake on the market due to its years of market dominance.
GlobalData currently forecasts that Imaavy will make $3.4bn for J&J in 2031.
Editor’s note: This article has been amended to remove mentions of the brand name ‘Imaavy’ in the context of SLE, as the therapy has not yet gained approval.
