CSL Behring announced today that the European Commission (EC) has granted marketing authorisation in all European Union (EU) member states for Respreeza® to treat patients with Alpha-1 antitrypsin deficiency (AATD). Respreeza®, a highly purified Alpha-1 protein derived from human plasma, is the only Alpha-1 proteinase inhibitor that has been proven in a prospective double blind, placebo controlled trial (the RAPID study) to significantly reduce the loss of lung tissue, slowing the progression of emphysema due to AATD. AATD is a hereditary condition marked by a lack of the Alpha-1 antitrypsin protein, whose main function is to protect the lungs from inflammation.
Once a marketing authorisation has been granted, the holder of the marketing authorisation can legally begin to market the medicine in all European countries. This means that Respreeza may be sold in the UK. It is up to the national NHS services to decide if they will reimburse (pay for) the cost of the treatment.