Pharmalink AB, a specialty pharma company, 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.”
Orphan drug designation is granted to drugs that are intended for the treatment of life threatening or chronically debilitating rare diseases where no therapeutic options either exist or are satisfactory. Rare diseases are those defined as having a prevalence of less than five in 10,000 in the European Union. The designation provides sponsors with development and commercial incentives, including 10 years of market exclusivity, prioritized consultation by the European Medicines Agency (EMA) on the development of the drug, including clinical studies, and certain exemptions from or reductions in regulatory fees. Click here for more information.