The Norwegian company’s lead product candidate has been granted orphan designation in Europe.
The European Medicines Agency (EMA) and the European Commission (EC) has now granted Betalutin orphan designation for treatment of follicular lymphoma in Europe. According to Nordic Nanovector, this will provide the company several advantages,
including reduced costs related to the clinical development program, as well as commercial exclusivity for ten years once the product reaches the market in Europe.
“With the orphan designation for Betalutin™ in the Europe, the company can receive protocol assistance, a type of scientific advice specific for designated orphan medicines and market exclusivity once the medicine is on the market. Fee reductions are also available. These benefits will help tremendously in the development and commercialization of an important new form of treatment of non-Hodgkin Lymphoma,” said Jan A. Alfheim, Nordic Nanovector CEO.
Betalutin is a pharmaceutical product candidate consisting of a radionuclide conjugated to a tumor seeking carrier/antibody, which can be used for irradiation of malignant metastasized tumors with minimal damage to nearby healthy normal tissue.
