One step closer to the first UK drug license for augmentation therapy for patients with severe alpha-1 antitrypsin deficiency
CSL Behring has announced today that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting a market authorisation to CSL’s alpha-1 antitrypsin augmentation therapy product Respreeza®.
Receiving a positive CHMP opinion (See EMA Website) marks an important milestone in the process of Respreeza® obtaining a market authorisation (= drug license) in all EU Member States, including the UK. The CHMP positive opinion will be transmitted to the European Commission (EC) to start the EC decision-making process on granting a centralised European drug license for Respreeza®, which we hope to be concluded later this year.
Lutz Bonacker, Senior Vice President & General Manager Commercial Operations, Europe, CSL Behring said: “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.”
However, once a drug license is granted by the EC, access to Respreeza® to UK patients will be subject to reimbursement of the drug by the NHS. As use of Respreeza® will be indicated in adults with documented severe alpha-1 antitrypsin deficiency and evidence of progressive lung disease as evaluated by a healthcare professional experienced in the treatment of Alpha-1, it is important that patients gain access to the care provided by a physician with sufficient experience in the field of Alpha-1, e.g. at the recently established West Midlands Alpha-1 Services