Global biotherapeutics leader CSL Behring announced that the US Food and Drug Administration (FDA) has approved 4- and 5-gram vial sizes for ZEMAIRA® [Alpha1-Proteinase Inhibitor (Human)], its therapy for treating Alpha 1 Antitrypsin Deficiency (Alpha 1). This approval is significant for the Alpha 1 community as ZEMAIRA was previously available only in a 1-gram vial. The 4- and 5-gram packaging reduces the number of vials necessary for reconstitution, thereby adding convenience by saving patients’ time and reducing waste.
ZEMAIRA dosing is weight-based, so a patient weighing 184 pounds currently requires five 1-gram vials. With the larger vial sizes, a majority of patients will be able to streamline their preparation of ZEMAIRA to a single vial per dose, saving time and reducing waste by requiring them to reconstitute and pool fewer vials. Room temperature storage coupled with the new larger vial sizes eases the burden of Alpha 1 therapy.
“Many Alpha 1 patients already experience the burden of weekly infusions,” said Dr. Robert Sandhaus, MD, PhD, FCCP, Clinical Director, Alpha 1 Foundation and Medical Director, AlphaNet. “These larger vial sizes of ZEMAIRA are an improvement that could make it much easier for patients by simplifying the steps necessary for preparation of their therapy.”
“We listened to our patients and are proud to address an unmet need for a new option that streamlines and expedites their current treatment regimen,” adds Laurel Omert, MD, Medical Director, Specialty Products, North America, CSL Behring. “The addition of these larger vials to the ZEMAIRA family builds on our long history of innovation and commitment to the Alpha 1 community.”
ZEMAIRA, a natural Alpha 1 protein derived from human plasma, has been proven to raise and maintain serum levels of alpha 1 antitrypsin protein (AAT) in patients. It has been available in the US market for over 15 years and is manufactured in Kankakee, Illinois.