Kedrion Biopharma announces that the U.S. Food and Drug Administration has accepted their Investigational New Drug (IND) application for a clinical study aimed at assessing efficacy and safety of a 10% intravenous immunoglobulin in the treatment of adult patients with primary immunodeficiency diseases (PID). This approval allows Kedrion to initiate clinical trial in the United States in coming months.
After the pilot phase of the project, which was carried out at Kedrion’s manufacturing and development hub in Bolognana, Italy, the clinical scale-up of this 10% Immunoglobulin was continued at Kedrion’s Hungarian facility in Gödöllő, where the clinical batches that will be used in the study are currently being produced. According to the plan, once the trial has been completed, the candidate will be produced (purification phase) at Kedrion’s new Castelvecchio Pascoli plant in Italy.
Kedrion is a leading biopharmaceutical company that specializes in the development, production and distribution of plasma-derived therapeutic products for use in treating serious diseases, disorders and conditions such as immune system deficiencies and coagulation disorders.
The Company operates through a fully integrated business model from the collection of plasma in its own centers in the United States, Hungary and Germany to fractionation and production in its manufacturing facilities located in Italy, Hungary and the United States.
Headquartered in Castelvecchio Pascoli (Italy), Kedrion has over 2,600 employees and a commercial presence in approximately 100 countries worldwide.
Kedrion places a high value on the welfare of those who benefit from its products, as well as on the people and the communities it serves.
Additional information about Kedrion can be found at kedrion.com