The US Food and Drug Administration (FDA) has awarded the second breakthrough therapy designation (BTD) to ‘s聽(J&J) nipocalimab for treating individuals with moderate-to-severe Sj枚gren鈥檚 disease (SjD).
This marks nipocalimab as the only investigational therapy to receive this designation for SjD.
Nipocalimab’s latest BTD is underpinned by data from the Phase II DAHLIAS study, which is a randomised, placebo-controlled, multicentre, and double-blind trial.
The study’s outcomes paved the way for the ongoing Phase III study, aiming to further assess nipocalimab’s efficacy and safety for patients with moderate-to-severe SjD.
The data from the Phase II DAHLIAS study showcased the 鈥渇irst-ever positive鈥� outcomes of an investigational neonatal crystallisable fragment receptor (FcRn) blocker as a potential targeted treatment of SjD.
An investigational monoclonal antibody, nipocalimab blocks FcRn with high affinity, potentially reducing levels of circulating immunoglobulin G antibodies without impacting other immune functions.
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By GlobalDataSjD is a chronic and debilitating autoantibody disease that can severely impact daily life and overall quality of life. It frequently affects glands responsible for saliva and tear production and can also cause systemic symptoms that affect multiple organs.
As compared to general population, SjD patients are at a potentially higher risk of developing B-cell lymphomas.
The initial BTD for nipocalimab was granted in February 2024 for treating alloimmunised pregnant people at high risk of severe haemolytic disease of the foetus and newborn (HDFN).
The therapy received several regulatory designations for various indications, including the US FDA鈥檚 fast-track status in July 2019 for the treatment of HDFN and warm autoimmune haemolytic anaemia; in December 2021 for treating generalised myasthenia gravis; and in March this year for foetal neonatal alloimmune thrombocytopenia treatment.
J&J聽Innovative Medicine Rheumatology and Immunology Disease Area leader and vice-president Terence Rooney said: 鈥淭oday鈥檚 announcement marks an important step forward in the continued research and development of nipocalimab, the first investigational FcRn blocker to demonstrate positive results in a Phase II study in adult patients with moderate-to-severe Sj枚gren鈥檚 disease.
鈥淲ith no treatments currently approved that may directly address the underlying cause(s) of the disease, innovation is critically needed to improve patient outcomes in Sj枚gren鈥檚 disease.鈥�
