FDA Grants Fast Track Review To Johnson & Johnson's Nipocalimab For Autoimmune Disorder That Affects Tears, Saliva

The U.S. Food and Drug Administration granted on Tuesday Fast Track designation to Johnson & Johnson’s JNJ investigational nipocalimab for moderate-to-severe Sjögren’s disease (SjD).

Last year, FDA granted Breakthrough Therapy designation (BTD) for the investigational therapy.

The Phase 2 DAHLIAS study, presented last year, represented the first-ever positive results of an investigational FcRn blocker as a potential targeted therapy in SjD. 

The study achieved the primary endpoint in the 15 mg/kg Q2W nipocalimab group, showing a greater than 70% relative average improvement in systemic disease activity at Week 24 compared to placebo and IgG reductions of more than 77%.

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Trends of improvement were similarly observed across multiple secondary endpoints. Safety and tolerability were consistent with other nipocalimab clinical studies.

Sjögren’s disease, also known as Sjögren’s syndrome, is a chronic autoimmune disorder that primarily affects the body’s exocrine glands (or moisture-producing glands), particularly those responsible for producing tears and saliva, leading to dry eyes and mouth.

Earlier this month, Johnson & Johnson decided to discontinue the Phase 3 VENTURA development program evaluating aticaprant, a kappa opioid receptor (KOR) antagonist, as an adjunctive treatment for major depressive disorder (aMDD). The move follows insufficient efficacy in the target patient population. The data confirmed aticaprant is safe and well-tolerated, and no new safety signals were identified.

In February, Sanofi SA SNY and Johnson & Johnson discontinued the E.mbrace phase 3 study evaluating a vaccine candidate for extraintestinal pathogenic E. coli. The companies determined that the vaccine candidate was not sufficiently effective at preventing invasive E. coli disease (IED) compared to placebo.

JNJ Price Action: Johnson & Johnson stock is up 0.71% at $164 at publication Tuesday.

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