J&J's FcRn Antibody Nipocalimab Designated for Breakthrough Therapy in China for gMG

ByMedView

The official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) announced that nipocalimab injection, a Class 1 new drug submitted by Johnson & Johnson, is proposed to be included in the breakthrough therapy designation for the indication of generalized myasthenia gravis (gMG). Public information shows that nipocalimab (M281) is an investigational anti-FcRn antibody acquired by Johnson & Johnson through the acquisition of Momenta for approximately $6.5 billion.

Screenshot source: CDE official website

The neonatal Fc receptor (FcRn) is widely expressed throughout the body and plays a central role in preventing the degradation of immunoglobulin G (IgG) antibodies. Nipocalimab, an antibody therapy targeting FcRn developed by Momenta, has the potential to treat various autoimmune diseases caused by autoantibodies. In August 2020, Johnson & Johnson acquired Momenta for approximately $6.5 billion, gaining access to the latter's pipeline projects, including its lead investigational product, nipocalimab.

According to reports, Nipocalimab can bind to FcRn, allowing autoantibodies taken up by monocytes and endothelial cells to be degraded within the cells rather than being released back into the bloodstream. Existing studies have shown that it can reduce IgG levels, including pathogenic autoantibodies in the blood circulation, by more than 75%.

▲Introduction to Nipocalimab (Image Source: Johnson & Johnson's official website)

Previously, nipocalimab was granted orphan drug designation by the U.S. FDA for the prevention of hemolytic disease of the fetus and newborn, and it has already achieved positive results in a Phase 2 clinical trial for the treatment of myasthenia gravis. In August 2021, it was approved in China to initiate clinical research for generalized myasthenia gravis. The recent inclusion as a proposed breakthrough therapy is another significant advancement for this drug in China.

Myasthenia Gravis is a rare disease where autoantibodies block neuromuscular synaptic signal transmission. In a Phase 2 clinical trial for myasthenia gravis, a significant response was observed in patients two weeks after receiving nipocalimab treatment.

According to the introduction at Johnson & Johnson's investor meeting held in November 2021, the company plans to explore the therapeutic potential of nipocalimab in various autoimmune diseases. Currently, Johnson & Johnson is conducting or planning eight registrational studies and four proof-of-concept studies, involving more than 11 indications. The company aims to define or redefine the standard of care for multiple autoimmune diseases.

Autoimmune diseases driven by autoantibodies include myasthenia gravis, fetal and neonatal hemolytic diseases, as well as other severe dermatological, rheumatological, neurological, hematological, and renal diseases, among others. It is hoped that the subsequent clinical development of nipocalimab will proceed smoothly, bringing new treatment options to patients as soon as possible.

References:

[1] Center for Drug Evaluation, National Medical Products Administration of China. Retrieved Jan 17, 2022, from https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d

[2] Johnson & Johnson to Acquire Momenta Pharmaceuticals, Inc., Expanding Janssen's Leadership in Novel Treatments for Autoimmune Diseases https://www.prnewswire.com/news-releases/johnson--johnson-to-acquire-momenta-pharmaceuticals-inc-expanding-janssens-leadership-in-novel-treatments-for-autoimmune-diseases-301114715.html

[3] JOHNSON & JOHNSON PHARMACEUTICAL BUSINESS REVIEW 2021. Retrieved November 19, 2021, from https://jnjpharmreview.virtualsession.events/register

[4] As J&J moves to split its business, execs lay out future R&D focus — and tout megablockbuster potential. Retrieved November 19, 2021, from https://endpts.com/as-jj-moves-to-split-its-business-execs-lay-out-future-rd-focus-and-tout-megablockbuster-potential/

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