FDA grants fast track designation to nipocalimab for Sjögren’s disease
DAHLIAS tested therapy's safety, efficacy in 163 adults with primary Sjögren’s
Nipocalimab, an experimental antibody-based therapy being developed by Johnson & Johnson, was granted fast track status by the U.S. Food and Drug Administration (FDA) for adults with moderate to severe Sjögren’s disease.
Fast track status is given to candidate therapies for serious health conditions with the aim of accelerating their development and regulatory review by providing more frequent meetings with the FDA and discussions about their development plan.
Results from a Phase 2 clinical trial called DAHLIAS (NCT04969812) supported nipocalimab’s fast track designation, along with its breakthrough therapy designation, which was given last November. This designation is also meant to accelerate the development and regulatory review of investigational therapies for serious or life-threatening conditions.
“This marks an additional important step forward in our efforts to bring meaningful advancements to people living with Sjögren’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,” Katie Abouzahr, MD, vice president, autoantibody portfolio and maternal fetal disease area leader at Johnson & Johnson Innovative Medicine, said in a company press release.
Sjögren’s disease is an autoimmune condition wherein the immune system attacks the glands responsible for producing tears and saliva, leading to the hallmark symptoms of dry eyes and mouth. The disease can also affect other parts of the body, however, including the joints, lungs, and nervous system. It’s classified as primary when it occurs on its own and as secondary when it develops alongside another autoimmune disorder.
The immune response in Sjögren’s is fueled by autoantibodies, most notably anti-Ro (SS-A) and anti-La (SS-B) antibodies, part of the immunoglobulin G (IgG) antibody class. Under normal circumstances, a protein receptor called neonatal Fc receptor (FcRn) binds to IgG antibodies to protect them from being broken down and extend the time they remain active in the bloodstream.
What is nipocalimab?
Nipocalimab is an antibody therapy that’s designed to inhibit FcRn, accelerating the rate at which IgG antibodies, including those implicated in Sjögren’s, are broken down and lowering their levels in the bloodstream. By doing this, the therapy may alleviate Sjögren’s symptoms and reduce overall disease severity.
DAHLIAS assessed the safety and efficacy of nipocalimab in 163 adults, ages 18-75, with moderate to severely active primary Sjögren’s disease. The participants were randomly assigned to one of two doses of nipocalimab (5 or 15 mg/kg) or a placebo every two weeks by infusion into a vein, or intravenously.
The trial met its primary goal and those who received the higher dose saw their systemic, or bodywide, disease activity drop by more than 70% after 24 weeks, or around six months, of treatment.
Both dosing regimens led to significant decreases in IgG levels, with reductions of up to 77.5% for the 15 mg/kg group and of 63.8% for the 5 mg/kg group from the start. Also, there were marked declines in autoantibody levels, including anti-Ro60, anti-Ro52, and anti-SSB antibodies.
The therapy was mostly well tolerated, with serious side effects occurring in about 7% of the patients treated with both doses and about 5% of those in the placebo group.
Patients with moderate to severe Sjögren’s disease are being actively enrolled in a Phase 3 clinical trial of nipocalimab called DAFFODIL (NCT06741969). The study is recruiting participants at sites in the U.S., Japan, Taiwan, and the U.K., and is expected to conclude in 2030.
The participants in DAFFODIL will be randomly assigned to nipocalimab or a placebo, along with standard of care treatment, for 48 weeks, or 11 months. Those who complete the treatment period will be able to enroll in an open-label long-term extension study where they’ll continue to receive nipocalimab for about 2.7 years.
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