News

Uplizna recommended for approval in EU as treatment for IgG4-RD

An advisory committee of the European Medicines Agency, or EMA — which evaluations medications for drug approval in the European Union — has recommended Uplizna (inebilizumab) for the treatment of adults with active IgG4-related disease (IgG4-RD). The positive opinion from the EMA’s Committee for Medicinal Products for Human…

Combining treatments may reduce risk of relapses in IgG4-RD

People with immunoglobulin G4-related disease (IgG4-RD) are more likely to relapse if they have allergies, multiple organ involvement, or low levels of complement proteins — but using corticosteroid treatments together with immunosuppressants may reduce this risk. That’s according to a meta-analysis of 24 studies that sought to identify potential…

Rituximab effective for all IgG4-RD disease types, study finds

Rituximab is effective for all four clinical profiles of immunoglobulin G4-related disease (IgG4-RD), but two IgG4-RD profiles, or phenotypes, may show poorer responses, according to a multicenter study in Europe. “Patients in the retroperitoneal and aortic and head and neck-limited phenotypes may be less responsive,” the researchers said, and…

Zenas secures up to $300M to advance obexelimab for IgG4-RD

Zenas Biopharma has secured up to $300 million from Royalty Pharma to accelerate the development of obexelimab, its investigational treatment that could provide much-needed relief for people with immunoglobulin G4-related disease (IgG4-RD). In exchange, Royalty Pharma will receive a share of royalties on sales of obexelimab, which is…

Diagnosing children with IgG4-RD requires flexibility, study finds

Diagnosing IgG4-related disease (IgG4-RD) in children may require a flexible framework involving many kinds of tests, as the disease often looks different in children than in adults, according to a review study from researchers in Italy. While IgG4-RD in adults usually affects multiple organs over time, in children it…

Sanofi’s Rilzabrutinib earns orphan drug status in EU for IgG4-RD

The European Medicines Agency has granted orphan drug designation to Sanofi’s rilzabrutinib as a potential treatment for immunoglobulin G4-related disease (IgG4-RD), according to a company press release. Orphan drug status is meant to support the development of potential treatments for life-threatening or chronically debilitating rare diseases for which…

Zenas sees results from obexelimab Phase 3 trial near year-end

Zenas Biopharma said it expects top-line results from INDIGO, a Phase 3 clinical trial testing obexelimab in people with immunoglobulin G4-related disease (IgG4-RD), “around year-end.” We are very pleased with the rapid advancement of our broad obexelimab development program,” Lonnie Moulder, founder and CEO of Zenas, said…

Salivary gland imaging can make it easier to diagnose IgG4-RD

Imaging of the salivary glands can help distinguish IgG4-related disease (IgG4-RD) from other disorders that can cause inflammation in those glands, a new study shows. The findings indicate people with salivary gland inflammation related to IgG4-RD tend to show distinctive patterns of damage to some of the tubes, or…

IgG4 levels shape autoimmune pancreatitis, study finds

Type 1 autoimmune pancreatitis (AIP), a type of IgG4-related disease (IgG4-RD) involving the pancreas, can look different depending on the levels of immunoglobulin G4 (IgG4), a study found. People with normal IgG4 levels typically had more limited damage in the pancreas and some issues outside it, the researchers found.