Sweden’s Pharmalink obtains OMP designation for Nefecon
The European Commission (EC) has granted orphan medicinal product (OMP) designation in the European Union (EU) to Swedish-based Pharmalink’s Nefecon (budesonide).
Nefecon will be given for patients with primary IgA nephropathy (IgAN), which is the most common form of glomerulonephritis that can occur at any age, but the clinical onset is commonly during the second or third decades of life.
It accounts for 10% of renal transplants among patients with primary glomerulonephritis in the US and between 7% and 20% of patients in Europe and Australia in long-term dialysis, as well as renal transplantation programmes.
Pharmalink CEO Johan Häggblad said: “Receiving orphan drug designation from the EC, in addition to the previous orphan drug designation granted by the US FDA, is an important event for Pharmalink.
“It highlights the need for new products for the treatment of primary IgAN, as well as our commitment to developing Nefecon for these patients.”
The drug already has orphan designation for IgAN in the US and completed a randomised, placebo-controlled Phase II study.
Also known as the NEfigan trial, the study was carried out on more than 150 IgAN patients at risk of developing end-stage renal disease (ESRD), under standardised rigorous blood pressure control.
Pharmalink is currently planning a Phase III registration trial.
The EC grants OMP designation to drugs that are intended for the treatment of life-threatening or chronically debilitating rare diseases.
With this designation, sponsors will receive development and commercial incentives, including market exclusivity for ten years.