RESPREEZA (human alpha-1 antitrypsin), proteinase inhibitor

No clinical benefit demonstrated compared to usual treatment of emphysema in alpha-1 antitrypsin deficient patients.

• RESPREEZA has a Marketing Authorisation in the maintenance therapy of severe and documented alpha-1 antitrypsin deficiency in adults, to slow the progression of emphysema. Patients must also receive optimal pharmacological and non-pharmacological treatment and show signs of progressive lung disease (e.g.: decrease in expected forced expiratory volume in one second [FEV1], reduced walking ability or increased number of exacerbations) assessed by a healthcare professional experienced in the treatment of alpha-1 antitrypsin deficiency.
• The clinical relevance of the observed result on the slowing of the loss of lung parenchymal density with RESPREEZA over placebo could not be estimated. Differences observed in CT scans have had no clinical and respiratory function translation.