FDA grants breakthrough therapy designation to nipocalimab for Sjögren’s disease
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The FDA has granted breakthrough therapy designation to nipocalimab, a novel neonatal Fc receptor blocker, for the treatment of moderate to severe Sjögren’s disease, according to a press release from Johnson & Johnson.
The monoclonal antibody is the first investigational therapy to secure this designation in Sjögren’s disease, the company stated.
“Today’s announcement marks an important step forward in the continued research and development of nipocalimab, the first investigational FcRn blocker to demonstrate positive results in a phase 2 study in adult patients with moderate to severe Sjögren’s disease,” Terence Rooney, vice president of rheumatology and immunology disease at Johnson & Johnson Innovative Medicine, said in the release. “With no treatments currently approved that may directly address the underlying cause(s) of the disease, innovation is critically needed to improve patient outcomes in Sjögren’s disease.
“This milestone underscores our unwavering commitment to develop novel, transformational therapies that may help address significant unmet need for patients living with autoantibody-driven diseases,” he added.
The breakthrough designation follows data from the phase 2 DAHLIAS study, in which treated patients demonstrated greater than 70% relative systemic disease activity improvement at 24 weeks vs. placebo, according to the release. The data represented “the first-ever positive results of an investigational FcRn blocker as a potential targeted therapy” in Sjögren’s disease, according to Johnson & Johnson. Further investigation is under way in a phase 3 trial.
Nipocalimab was previously designated as a breakthrough therapy in February for the treatment of alloimmunized pregnant individuals at high risk for severe hemolytic disease of the fetus and newborn.
According to the FDA, the breakthrough therapy designation is intended to expedite the development and review of drugs aimed at serious conditions. Drugs that receive the designation are eligible for intensive guidance on an efficient drug development program, organizational commitment involving senior managers, and all benefits of the FDA fast track process.
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