Date:29 June, 2015

Marketing Authorisation for Respreeza

CSL Behring announced today that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorisation for Respreeza®, a highly purified alpha-1 protein derived from human plasma, indicated to treat patients with alpha-1 antitrypsin deficiency (AATD).

Respreeza is known as Zemaira in countries outside Europe.

The implications for a Europe-wide marketing authorisation has potentially huge implications for those countries in which no augmentation therapy is licensed – the United Kingdom included.