Pharmalink, the specialty pharma company developing high-value, global products for patients with significant unmet medical needs, announces that the European Commission (EC) has granted Orphan Medicinal Product (OMP) designation in the European Union (EU) to Nefecon® (budesonide), the company’s treatment for patients with primary IgA nephropathy (IgAN).
Nefecon, which already has orphan designation for IgAN in the US, has successfully completed a randomized, placebo-controlled Phase 2 study (the NEFIGAN trial) in more than 150 IgAN patients at risk of developing end stage renal disease (ESRD), under standardized rigorous blood pressure control. Full data and analysis of the trial is expected to be published in a peer-review journal. A Phase 3 registration trial is currently being planned.
Johan Häggblad, Pharmalink CEO, commented: “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.”