Danish Medicines Council Grants Approval for CSL Behring’s Respreeza as Standard Treatment for Severe Alpha-1 Antitrypsin Deficiency Patients
HATTERSHEIM AM MAIN, Germany, Jan. 24, 2020 – Global biopharmaceutical company CSL Behring announced that the Danish Medicines Council has published its final decision regarding the approval of human Alpha-1 Antitrypsin Deficiency (AATD) therapy and Respreeza®, which will now become the standard treatment for slowing the progression of emphysema arising from AATD. This latest development will allow CSL Behring to supply Alpha-1 patients in Denmark with an effective therapy to mitigate the effects of AATD.
Respreeza® is a highly purified alpha-1 protein, derived from human plasma and indicated to treat patients with AATD. It is the only alpha-1 proteinase therapy that in a randomized controlled trial has been proven to be disease-modifying, by significantly reducing the loss of lung tissue, thereby 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. 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.
The Danish Medicines Council estimates that this decision could benefit up to 80 patients in Denmark who, currently, are eligible for treatment with AAT therapy.
Claus Astradsson, Chairman of “Alfa-1 Danmark”, the Danish Alpha-1 patient association, said: “First of all, our quality of life will be markedly improved. It will offer us a life closer to normality, negating or slowing the loss of lung and exercise capacity and allowing us to live a life without fear. We will be able to see our children and grandchildren grow up and will have the opportunity to travel, due to the fact that we can learn to administer the intravenous injection ourselves. This also means that we are offered a real chance of remaining employed until retirement.”
Miriam O’Day, President and CEO of the Alpha-1 Foundation added: “This is fantastic news; the United States’ experience with augmentation therapy has shown the great impact this therapy can have on an Alpha’s quality of life. We believe this availability will have a profound impact on the lives of Danish Alphas. We would like to thank CSL Behring for their unwavering dedication and great work in the Alpha-1 community.”
Johanna Haapkylae MD, Head of Respiratory, CSL Behring Nordic, stated: “This is a very good day for patients and their families. We are extremely pleased that we have been able to deliver evidence that supported the decision to make Respreeza® available for patients in Denmark, which underscores our continued dedication to deliver on our promise to patients with life-threatening diseases.”