CSL Behring has issued the following statement:
“CSL Behring submitted the Marketing Authorisation Application to the EMA in December 2013. We are confident in the quality of the data produced by the CSL Behring RAPID trial, and look forward to working with the agency to supply any additional information that may be required to secure regulatory approval in Europe.”
The European Medicines Agency is a decentralised agency of the European Union, located in London. The Agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union.
The RAPID Clinical Trial was multi-centre, multi-national trial involved patients with homozygous Alpha-1 (ZZ) randomly selected to receive either alpha-1 antitrypsin (Zemaira) intravenously at 60 mg/kg weekly or a placebo over two years. CT scan lung density was measured at baseline, three months, one and two years. Secondary endpoints included spirometry, changes in exercise capacity and the rate of pulmonary exacerbations over two years.
The RAPID Trial was the first well-powered randomised, placebo-controlled trial to use CT scan lung density as the primary outcome measure. CT scans are currently considered the most sensitive measure of emphysema detection.
Zemaira is CSL Behring’s alpha-1 antitrypsin product for augmentation therapy.