CSL Behring receives positive CHMP opinion for Respreeza
Posted: 29 June 2015 |
The Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorisation in the EU for CSL Behring’s Respreeza…
The Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorisation in the EU for CSL Behring‘s Respreeza.
Respreeza is a highly purified alpha-1 protein derived from human plasma, indicated to treat patients with alpha-1 antitrypsin deficiency (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. Respreeza replaces the protein that these patients are missing and raises the alpha-1 antitrypsin levels in their blood, which can help to protect the lungs from damage due to inflammation.
Patients treatment with Respreeza exhibited lower annual rate of lung density decline
“CSL Behring continues to make strides towards fulfilling our promise to improve the lives of our patients. This positive opinion from CHMP brings us closer to providing Respreeza as a new treatment option to the AATD community in Europe,” said Lutz Bonacker, Senior Vice President & General Manager Commercial Operations, Europe, CSL Behring.
The CHMP positive opinion will be transmitted to the European Commission (EC) to start the EC decision-making process. The EC may then grant a marketing authorisation for Respreeza as a maintenance treatment to slow the progression of emphysema in adults with documented severe alpha-1 proteinase inhibitor deficiency. CSL Behring’s RAPID study results were considered as part of this submission. According to findings of the study, patients with AATD treated with alpha-1 proteinase inhibitor therapy exhibited a lower annual rate of lung density decline compared to placebo, when measured using chest computed tomography, at full inspiration. This demonstrated that Respreeza significantly slows the progression of emphysema in these critically ill patients.