J&J's immune disorder drug succeeds in mid and late-stage studies

[February 06, 2024]  (Reuters) -Johnson & Johnson's experimental drug to treat two autoimmune disorders helped relieve symptoms when tested in adult patients in mid-stage and late-stage trials, the company said on Monday.

The drug, nipocalimab, significantly reduced symptoms of generalized myasthenia gravis (gMG) in a late-stage study, and in a mid-stage study helped reduce Sjögren's disease severity, J&J said.

GMG is caused by an abnormal immune reaction that weakens the skeletal muscles, especially those that control the eyes, mouth, throat and limbs. The disorder affects about 14 to 40 individuals per 100,000 in the United States, according to National Organization for Rare Disorders.

The U.S. health regulator last year approved Argenx SE's under-the-skin injection, Vyvgart Hytrulo, for the treatment of gMG.

Nipocalimab and Vyvgart Hytrulo block a receptor called FcRn and help reduce overall levels of IgG, a type of antibody responsible for gMG.

Vyvgart Hytrulo is available in the U.S. at a list price of $15,773 and is expected to generate about $2.5 billion in revenue for the treatment of gMG alone.

AstraZeneca's intravenous injection, Soliris, which it acquired through a $39 billion buyout of Alexion Pharmaceuticals in 2020, is another treatment option available for patients with this condition.

The logo of Johnson & Johnson is seen on the top of a Brussels' office of the company in Diegem, Belgium September 21, 2023. REUTERS/Yves Herman/File Photo

In Sjögren's disease, where J&J's nipocalimab also showed promise, the immune system attacks moisture-producing glands in the eyes, mouth, and other parts of the body.

Sjögren's disease commonly affects women and usually occurs between 45 and 55 years of age, according to American College of Rheumatology.

Full results from both the studies would be presented at a scientific medical congress this year, J&J said.

(Reporting by Mariam Sunny in Bengaluru; Editing by Shailesh Kuber)

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