Nefecon has become the first and only approved treatment in the EU for primary immunoglobulin A nephropathy (IgAN), a rare, progressive kidney disease.
The European Medicines Agency said that the medicine “was shown to be effective at lowering the level of excess protein in the urine in patients with IgAN, indicating an improvement in kidney function”.
The modified-release budesonide capsules have been designated an orphan medicinal product qualifying for 10-year market exclusivity.
The drug was developed in collaboration with Calliditas Therapeutics, and will be marketed in Europe by STADA Arzneimittel, with the first launch in Germany.
Primary IgAN, also known as Berger’s disease, is a chronic, debilitating and life-threatening kidney disease. It is an orphan disease and is estimated to affect approximately 200,000 people in the EU and UK.
“The problem with IgA nephropathy is that most patients do not know that they have this disease, and a large proportion of patients are diagnosed by coincidence,” explained Professor Jonathan Barratt, Mayer Professor of Renal Medicine at the University of Leicester. “There is a significant unmet need in the treatments we can offer our patients.”
The developers received conditional approval in July from the European Commission for Nefecon in adult patients with IgAN at risk of rapid disease progression with a urine protein-to-creatinine ratio ≥1.5 g/gram.
The nephrology drug complements STADA’s existing epoetin zeta kidney treatment, one of the first biosimilars approved in the EU.