Nipocalimab nets FDA fast-track designation for Sjögren’s disease
The FDA has granted fast-track designation to nipocalimab for the treatment of Sjögren’s disease, according to a press release from Johnson & Johnson.
The announcement comes 5 months after the investigational monoclonal antibody received breakthrough therapy designation from the FDA for the same indication.
“The combined value of securing both fast-track and breakthrough therapy designations reflects J&J’s commitment to bringing much-needed innovation to patients with Sjögren’s disease,” Katie Abouzahr, MD, vice president, autoantibody portfolio and maternal fetal disease area leader for Johnson & Johnson Innovative Medicine, told Healio.
“These designations provide the opportunity to more closely collaborate with the FDA through more frequent interactions throughout the drug development and review process,” she added. “Together, they provide a strong path to deliver a potential new therapy to patients as quickly as possible.”
The Sjögren’s Foundation commended the move in a statement to Healio.
“There is an urgent need for treatment options for Sjögren's disease that go beyond symptom management and target the underlying systemic disease,” Janet E. Church, president and CEO of the Sjögren’s Foundation, said. “The Sjögren’s Foundation supports research and innovation that advance potential new therapies, and we are encouraged by efforts to bring more attention to this complex autoimmune disease.”
Nipocalimab (Johnson & Johnson) is being investigated for use in adults with moderate to severe Sjögren’s disease, an autoimmune disease for which there are currently no approved therapies. In addition to joint pain, fatigue and other symptoms, Sjögren’s is associated with dry eyes and mouth, as well as increased risk for non-Hodgkin lymphoma.
Nipocalimab is designed to block the neonatal Fc receptor (FcRn) and reduce circulating IgG antibody levels, “potentially without impact on other immune functions,” according to the release.
The drug garnered breakthrough therapy designation in November following the results of a phase 2 study called DAHLIAS. Compared with patients on placebo, those treated with 15 mg/kg of nipocalimab once every 2 weeks had a greater than 70% relative average improvement in systemic disease activity after 24 weeks, as well as greater than 77% reductions in IgG, according to the release.
References:
Cancer risk with Sjögren’s. https://www.arthritis.org/health-wellness/about-arthritis/related-conditions/other-diseases/non-hodgkins-lymphoma-with-sjogrens-syndrome. Published June 7, 2021. Accessed March 18, 2025.
Read more about