{"id":826859,"date":"2025-03-18T08:34:29","date_gmt":"2025-03-18T12:34:29","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/nipocalimab-the-first-and-only-investigational-treatment-to-be-granted-u-s-fda-breakthrough-therapy-designation-for-the-treatment-of-adults-with-moderate-to-severe-sjogrens-disease-has-now-receiv\/"},"modified":"2025-03-18T08:34:29","modified_gmt":"2025-03-18T12:34:29","slug":"nipocalimab-the-first-and-only-investigational-treatment-to-be-granted-u-s-fda-breakthrough-therapy-designation-for-the-treatment-of-adults-with-moderate-to-severe-sjogrens-disease-has-now-receiv","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/nipocalimab-the-first-and-only-investigational-treatment-to-be-granted-u-s-fda-breakthrough-therapy-designation-for-the-treatment-of-adults-with-moderate-to-severe-sjogrens-disease-has-now-receiv\/","title":{"rendered":"Nipocalimab, the first and only investigational treatment to be granted U.S. FDA Breakthrough Therapy designation for the treatment of adults with moderate-to-severe Sj\u00f6gren’s disease, has now received Fast Track designation"},"content":{"rendered":"
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PR Newswire<\/p>\n<\/p><\/div>\n

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\n Sj\u00f6gren’s disease (SjD)<\/i>
\n \u00a0is a <\/i>
\n prevalent, debilitating autoantibody disease with no FDA-approved advanced treatments<\/i>\u00a0\u00a0<\/p>\n

\n The Company is actively enrolling patients in the Phase 3 DAFFODIL study\u00a0<\/i>\u00a0<\/p>\n

\n This marks the fourth nipocalimab FDA Fast Track designation <\/i>\n <\/p>\n

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\n SPRING HOUSE, Pa.<\/span>
\n <\/span>, March 18, 2025<\/span><\/span> \/PRNewswire\/ — Johnson & Johnson (NYSE: JNJ) today announced that the U.S. Food and Drug Administration (FDA) has granted investigational nipocalimab Fast Track designation (FTD) for the treatment of adult patients with moderate-to-severe Sj\u00f6gren’s disease (SjD), having previously been granted Breakthrough<\/a>\u00a0Therapy designation (BTD) for the investigational therapy late last year. Currently, no advanced therapies are approved to treat this disease.<\/p>\n

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\n
\n \"(PRNewsfoto\/Johnson
\n <\/a>\n <\/p>\n<\/p><\/div>\n

Building upon the BTD, which nipocalimab is the first and only therapeutic to receive for\u00a0SjD, the U.S. FDA’s FTD is also designed to accelerate the delivery of new therapeutics to patients by facilitating the development and expediting the review of drugs that demonstrate the potential to treat serious conditions and help address unmet needs for serious or life-threatening conditions.<\/p>\n

“This marks an additional important step forward in our efforts to\u00a0bring meaningful advancements to people living with Sj\u00f6gren’s disease, a serious and debilitating condition. We look forward to continuing to work closely with the FDA to advance the clinical development of nipocalimab and potentially provide a much-needed treatment option for this community,” said Katie Abouzahr,\u00a0M.D., Vice President,\u00a0Autoantibody Portfolio and Maternal Fetal Disease Area Leader, Johnson & Johnson Innovative Medicine.<\/p>\n

There are no FDA-approved treatments that directly address the underlying causes of this complex disease, associated with serious health consequences including chronic dryness of moisture producing glands that may lead to systemic complications such as joint pain, fatigue and inflammation in multiple organ systems.1,2,3<\/sup>\u00a0These systemic complications can lead to an increased risk of mortality and associated health conditions, including a 20 times greater risk of developing B-cell lymphomas when compared to the general population.1,4<\/sup>\u00a0<\/p>\n

The Phase 2 DAHLIAS study, the results of which were presented last year<\/a>, represented the first-ever positive results of an investigational FcRn blocker as a potential targeted therapy in SjD.\u00a0The study<\/a>\u00a0achieved 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%.5<\/sup> Trends of improvement were similarly observed across multiple secondary endpoints.5<\/sup> Safety and tolerability were consistent with other nipocalimab clinical studies.5<\/sup><\/p>\n

\n ABOUT SJ<\/b>
\n \u00d6GREN’S DISEASE <\/b>\n <\/p>\n

Sj\u00f6gren’s disease (SjD) is one of the most prevalent autoantibody-driven diseases for which no therapies are currently approved that treat the underlying and systemic nature of the disease.1<\/sup>\u00a0It is a chronic autoimmune disease that is estimated to impact approximately four million people worldwide and is nine times more common in women than men.6,7<\/sup>\u00a0SjD is characterized by autoantibody production, chronic inflammation, and lymphocytic infiltration of exocrine glands. Most patients are affected by mucosal dryness (eyes, mouth, vagina), joint pain and fatigue.1<\/sup>\u00a0More than 50% of SjD patients have a moderate to severe form of the condition, and disease burden can be as high as that of rheumatoid arthritis or systemic lupus erythematosus. It is usually associated with impaired quality of life and functional capacity.6.8,9<\/sup>\u00a0<\/p>\n

\n ABOUT DAHLIAS <\/b>\n <\/p>\n

DAHLIAS (NCT04968912<\/a>)\u00a0is a Phase 2 multicenter, randomized, placebo-controlled double-blind study to evaluate the effects of nipocalimab in participants with primary Sj\u00f6gren’s disease. DAHLIAS is a Phase 2 dose-ranging study for adults with moderately-to-severely active primary SjD who were seropositive for anti-Ro60 and\/or anti-Ro52 IgG antibodies. 163 adults aged 18-75 were randomized 1:1:1 to receive intravenous nipocalimab at 5 or 15 mg\/kg or placebo every 2 weeks through Week 22 and received protocol-permitted background standard of care. Safety assessments were conducted through Week 30. The primary endpoint was change in baseline in the ClinESSDAI (Clinical European League Against Rheumatism Sj\u00f6gren’s Syndrome Disease Activity Index) Score at Week 24. ClinESSDAI is a systemic diseases activity index designed to measure disease activity in patients with primary SjD based on 11 domains including: constitutional, lymphadenopathy, glandular, articular, cutaneous, respiratory, renal, muscular, peripheral nervous system, central nervous system, and hematological.\u00a0<\/p>\n

\n ABOUT NIPOCALIMAB<\/b>\n <\/p>\n

Nipocalimab is an investigational monoclonal antibody, designed to bind with high affinity to block FcRn and reduce levels of circulating immunoglobulin G (IgG) antibodies potentially without impact on other immune functions. This includes autoantibodies and alloantibodies that underlie multiple conditions across three key segments in the autoantibody space including Rare Autoantibody diseases, Maternal Fetal diseases mediated by maternal alloantibodies and Rheumatic diseases.5,10,11,12,13,14,15,16.17 <\/sup>Blockade of IgG binding to FcRn in the placenta is also believed to limit transplacental transfer of maternal alloantibodies to the fetus.18<\/sup>,19<\/sup><\/p>\n

The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have granted several key designations to nipocalimab including:\u00a0\u00a0<\/p>\n