Nipocalimab Gets FDA Breakthrough Status
- Nipocalimab targets moderate-to-severe Sjogren's disease
- No current treatments address Sjogren's disease cause
Johnson & Johnson has announced that the US Food and Drug Administration (FDA) has granted breakthrough therapy designation to nipocalimab. This treatment is intended for adults living with moderate-to-severe Sjogren's disease. Sjogren's disease is a chronic autoimmune disorder where the immune system attacks the glands that produce moisture in the eyes, mouth, and other parts of the body. Currently, there are no approved treatments that directly address the underlying cause of the disease.
The breakthrough therapy designation supports further evaluation of nipocalimab through a phase 3 study, which is currently underway. The FDA's decision is based on data from a phase 2 study that evaluated the efficacy and safety of nipocalimab in treating adult patients with moderate-to-severe Sjogren's disease.