News

The U.S. Food and Drug Administration (FDA) has accepted for review the biologics license application  seeking approval of Truxima (CT-P10), Celltrion‘s biosimilar to Rituxan (rituximab), for the same indications as Rituxan. The FDA’s decision is expected by the first quarter of 2018. If approved, Truxima will become available for two…

Patients with eosinophilic granulomatosis with polyangiitis (EGPA, or Churg-Strauss syndrome) who receive scheduled Rituxan (rituximab) therapy have lower relapse rates than those who are given Rituxan only during a relapse, a new study shows. The study titled, “Scheduled rituximab maintenance reduces relapse rate in eosinophilic granulomatosis with polyangiitis,” was…

A new study suggests that patients with ANCA-associated vasculitis (AAVs) may be at an increased risk of developing ischemic stroke and coronary artery disease. The study, “Risk of coronary artery disease and ischemic stroke in patients with ANCA-associated vasculitis. A French population-based study,” was…

Patients with granulomatosis with polyangiitis (GPA) — formerly known as Wegener’s granulomatosis — with severe inflammation in the eyes may significantly benefit from the anti-CD20 antibody Rituxan (rituximab). In the study, “Rituximab Induction and Maintenance Treatment in Patients…

More than one detection technique may be necessary to confirm the diagnosis of granulomatosis with polyangiitis (GPA), a type of vasculitis, researchers found. The study found that samples that had been previously considered negative for GPA when tested for the presence of ANCA proteins were actually positive when researchers used…

The Phase 3 ADVOCATE trial, evaluating ChemoCentryx‘s investigational drug avacopan (formerly CCX168) for the treatment of anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis is now enrolling participants. The update is part of the company’s financial report for the second quarter of 2017. The study (NCT02994927), which aims to evaluate the safety…

People with anti-neutrophil cytoplasmic antibodies (ANCA)-associated vasculitis have a lesser chance of relapse if they continue with maintenance treatment for two years instead of one, according to the results of a clinical trial. The trial, led by researchers at the Hôpital Européen Georges-Pompidou in France, also showed that patients…

HemaCare Corporation‘s recent expansion of its disease state materials portfolio includes serums from rare diseases such as granulomatosis with polyangiitis (GPA). The Los Angeles-based supplier of human blood and immune cells for biotech research added to the portfolio in response to increased demand from its customers in the drug…

Physicians, specialists, patients and families touched by vasculitis nationwide and around the world gathered June 23 at the Vasculitis Foundation’s 2017 International Vasculitis Symposium in Chicago. “Physicians and patients around the world have been looking to us for education and support for…

The European Commission (EC) has approved the use and marketing in Europe of Rixathon, a biosimilar to Roche’s MabThera (rituximab). The decision follows a positive review of Rixathon by the Committee for Medicinal Products for Human Use (CHMP) last April in response to Sandoz’s marketing application.