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Talecris inhaled Alpha-1 treatment gets European orphan drug status
RESEARCH TRIANGLE PARK, N.C.—Talecris Biotherapeutics, Inc. announced today that the European Commission followed an opinion of the Committee for Orphan Medicinal Products (COMP) and has granted orphan drug designation to Talecris’ alpha-1 proteinase inhibitor (human) for inhalation use in the treatment of congenital Alpha1-Antitrypsin Deficiency (also known as AAT Deficiency or Alpha-1).
Currently, there are no approved aerosolized treatments available for augmentation therapy for AAT Deficiency.
By providing incentives to the pharmaceutical industry, the EU legislative framework for orphan medicines encourages the development of products intended for the diagnosis, prevention or treatment of life-threatening or chronically debilitating conditions impacting no more than 5 in 10,000 people in the European Union. The initiative helps to give patients suffering from rare diseases access to the same quality of treatment as other patients.
