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 Sjogren's Disease, Has Now Received Fast Track Designation
March 19, 2025
March 19, 2025
NEW BRUNSWICK, New Jersey, March 19 -- Johnson and Johnson issued the following news release:
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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 Sjogren's disease, has now received Fast Track designation
Sjogren's disease (SjD) is a prevalent, debilitating autoantibody disease with no FDA-approved advanced treatments
* * *
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 Sjogren's disease, has now received Fast Track designation
Sjogren's disease (SjD) is a prevalent, debilitating autoantibody disease with no FDA-approved advanced treatments