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 /PRNewswire/ -- Global biotherapeutics leader CSL Behring today announced that the Danish Medicines Council has published its final decision, approving human Alpha 1 Antitrypsin (AAT) therapy and Respreeza® as standard treatment for slowing the progression of emphysema arising from Alpha 1 Antitrypsin Deficiency (AATD). CSL Behring is now able to provide the therapy to patients in Denmark with immediate effect.
Respreeza® is a highly purified alpha-1 protein, derived from human plasma and indicated to treat patients with Alpha 1 Antitrypsin Deficiency (AATD). It is the only Alpha 1 proteinase therapy that in a randomised 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 Alpha 1 Antitrypsin Deficiency.
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."
Johanna Haapkylae MD, Head of Respiratory, CSL Behring Nordic, said: "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."
About Alpha 1 Antitrypsin Deficiency
Alpha 1 Antitrypsin Deficiency is an inherited condition that can result in severe lung disease in adults and liver disease at any age, as well as other less known manifestations such as panniculitis, a skin disease. AATD is the most commonly known genetic risk factor for emphysema. Low levels or absence of the protective protein Alpha 1 Antitrypsin, which is produced by the liver, characterise AATD.
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by its promise to save lives. Focused on serving patients' needs by using the latest technologies, we develop and deliver innovative therapies that are used to treat coagulation disorders, primary immune deficiencies, hereditary angioedema, respiratory disease, and neurological disorders. The company's products are also used in cardiac surgery, burn treatment and to prevent hemolytic disease of the newborn.
CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. The parent company, CSL Limited (ASX: CSL) (USOTC: CSLLY), headquartered in Melbourne, Australia, employs more than 25,000 people, and delivers its life-saving therapies to people in more than 70 countries. For inspiring stories about the promise of biotechnology, visit Vita CSLBehring.com/vita and follow us on Twitter.com/CSLBehring.
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