05:02 PM EST, 11/11/2024 (MT Newswires) -- Johnson & Johnson ( JNJ ) said late Monday that the US Food and Drug Administration has granted nipocalimab breakthrough therapy designation to treat adults living with moderate-to-severe Sjogren's disease, a chronic autoantibody disease.

This designation supports further evaluation of the investigational treatment through a phase 3 study, which is underway, the drugmaker said.

The FDA's decision is supported by data from a phase 2 study evaluating the efficacy and safety of nipocalimab in treating adult patients with moderate-to-severe SjD, the company said.

This regulatory milestone is the second for nipocalimab; the first was in February to treat alloimmunized pregnant individuals at high risk of severe hemolytic disease of the fetus and newborn, the company said.