Johnson & Johnson's $6.5B Acquisition Yields FcRn Antibody Nipocalimab Nominated for Priority Review in China
Johnson & Johnson
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On November 12, the CDE website announced Johnson & JohnsonNicalimab InjectionProposed to be included in the priority review, applicable for the treatment ofAdult patients with generalized myasthenia gravis (gMG) who are seropositiveAndAdolescent patients (over 12 years old)。
Nipocalimab is developed by Johnson & Johnson throughAn FcRn antibody in development acquired for approximately $6.5 billion through the acquisition of Momenta Pharmaceuticals. In August this year, the drug was submitted for marketing approval in the United States for the treatment of myasthenia gravis. Being included in the CDE’s proposed priority review means that the drug is also expected to be submitted for marketing approval in China soon.
Screenshot source: CDE official website
Myasthenia Gravis (MG) is an autoimmune disorder. In MG, the immune system mistakenly attacks proteins at the neuromuscular junction, producing antibodies (For example, anti-acetylcholine receptor [AChR], anti-muscle-specific tyrosine kinase [MuSK], or anti-low-density lipoprotein receptor-related protein 4 [LRP4]), these antibodies can interfere with or disrupt normal function, preventing signals from being transmitted from nerves to muscles.
The initial manifestation of MG is often ocular.However, about 85% of patients will develop symptoms beyond ocular muscles, progressing to generalized myasthenia gravis (gMG).In China, gMG has been included in the "First Batch of Rare Disease Catalog".
As an FcRn antibody,NicalimabAiming to block FcRn with high affinity binding and reduce circulating immunoglobulin G (IgG) antibody levels (PackageIncluding autoantibodies and alloantibodies), while maintaining immune function without causing widespread immunosuppression. Blocking the binding of IgG to FcRn in the placenta is also considered to prevent the transfer of maternal alloantibodies across the placenta to the fetus.
The FDA submission for Nicarlimab is based on data from the Phase III study Vivacity-MG3.. The primary endpoint of the study was the average change in MG-ADL score from baseline during weeks 22, 23, and 24 in antibody-positive patients, with a key secondary endpoint including changes in the Quantitative Myasthenia Gravis (QMG) score. The study data showed:
In terms of the primary endpoint, patients receiving Nicarlimab + Standard of Care (SOC)Improved by 4.70 points on the MG-ADL score, significantly higher than the 3.25-point improvement from baseline achieved by patients receiving placebo + SOC treatment in weeks 22, 23, and 24 (P=0.002)；
According to QMG measurements, at weeks 22 and 24, compared with placebo + SOC,Nicalimab + SOC Significantly Improves Strength and Function in Different Muscle Groups (P<0.001)。
Weeks 22, 23, and 24, compared with placebo + SOC,The MG-ADL score (improved ≥2 points from baseline) was significantly higher with Nicallimab + SOC. (P=0.021), further indicating the potential of nicotinamide treatment to alleviate the impact of gMG on patients' daily lives.
In terms of safety and tolerability, it was consistent with other nicarlimab studies. The overall incidence of adverse events, serious adverse events, and adverse events leading to discontinuation was similar to the placebo + current SOC group.
Screenshot source:Insight Database
Nicalimab in combination with SOC treatment achieved the primary endpoint of the study – namelyTotal Serum IgG Decreased by -69%, as well as two secondary endpoints—namely, MG-ADL and QMG (indicators of disease activity). Among the five patients,Four patients had minimal symptoms at the end of the treatment period.(MG-ADL score 0-1).
Nicarlimab was well tolerated over a six-month period,Similar to the tolerability observed in adult participants in the Vivacity-MG3 studyNo serious adverse events occurred, and no discontinuation of the drug due to adverse events.
Screenshot source:Insight Database
The press release from Johnson & Johnson stated that this isThe First FcRn Blocker Demonstrating 24 Weeks of Sustained Disease Control in Antibody-Positive Adolescents Aged 12-17, expanding the research population of Nicallizumab.
Insight database shows,In China,Nicalimab is undergoing multiple studies, besidesIn addition to myasthenia gravis, the indications also include chronic inflammatory demyelinating polyneuropathy and warm antibody type autoimmune hemolytic anemia.
Screenshot source:Insight Database
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