ZLB Behring today announced that it has been granted a license by the U.S. Food and Drug Administration (FDA) to produce Alpha-1 Proteinase Inhibitor (Human), The embedded asset has been deleted:
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The highly automated, 113,000 square-foot, state-of-the-art manufacturing facility provides a high degree of accuracy in the manufacturing operation. This supports product safety and operational efficiency as production volumes are increased to meet patient needs. The first floor of the new building houses the manufacturing and warehouse areas; the second floor contains the mechanical areas to support production; and the third floor includes laboratories, pilot facilities and administrative offices.
"We are proud to reinforce our commitment to patients through the opening of this new facility, which will enable us to triple our production of Zemaira," said Randy Furby, senior vice president and general manager of the Kankakee plant. "We will continue to explore opportunities to expand our production capabilities to meet the needs of those with Alpha-1 Antitrypsin deficiency (Alpha-1)."
About Alpha-1 Antitrypsin Deficiency
Alpha-1 Proteinase Inhibitor is an anti-inflammatory protein that protects the tissue of the body. One of its most important roles is to shield the delicate tissues of the lungs by binding to neutrophil elastase, an enzyme released by certain white blood cells that digests bacteria and other foreign substances in the lungs. When a person who is deficient in Alpha-1 Proteinase Inhibitor inhales irritants or contracts a lung infection, the neutrophil elastase released to protect the lungs can continue on to injure healthy lung tissue. Repeated injury to the normal structure of the lungs can eventually result in emphysema. Once a patient with Alpha-1 develops symptoms, it can take an average of seven years and visits to five different healthcare professionals before the correct diagnosis is made. Once diagnosed with emphysema as a result of the condition, adults with Alpha-1 face progressive loss of lung function that can significantly impact everyday life and life expectancy.
Symptoms of Alpha-1 include shortness of breath on exertion, wheezing, and coughing. Because wheezing and shortness of breath are common symptoms, Alpha-1 is often misdiagnosed as other chronic lung diseases, such as chronic obstructive pulmonary disease (COPD) or asthma.
Researchers estimate that up to 100,000 adults and children in the U.S. have severe Alpha-1, and 2.5 million people nationwide may be carriers. Up to 95% of people with the deficiency may be undiagnosed.
About Alpha-1 Proteinase Inhibitor (Human) Zemaira
Zemaira is indicated for chronic augmentation and maintenance therapy for adults with Alpha-1 Proteinase Inhibitor deficiency and emphysema. Clinical data demonstrating the long-term effects of chronic augmentation therapy with Zemaira are not available.
As with other Alpha-1 therapies, Zemaira may not be appropriate for the following adult individuals as they may experience severe reactions, including anaphylaxis: individuals with a known hypersensitivity and/or history of anaphylaxis or severe systemic reaction to Alpha-1 Proteinase Inhibitor products or their components and individuals with selective IgA deficiencies who have known antibodies against IgA.
In clinical studies, the following treatment-related adverse reactions were reported in 1% of subjects: asthenia (fatigue), injection-site pain, dizziness, headache, paresthesia (tingling) and pruritus (itching).
Zemaira is derived from human plasma. As with all plasma-derived products, the risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.
About ZLB Behring
ZLB Behring is a global leader in the plasma protein biotherapeutics industry. Dedicated to improving the quality of life for patients throughout the world, ZLB Behring provides safe and effective plasma-derived and recombinant products and offers patients a wide range of related services. The company’s broad portfolio of life-saving therapeutics is used in the treatment of individuals with hemophilia and other bleeding disorders, immune deficiency disorders, and inherited emphysema; for the prevention of hemolytic diseases of the newborn; in cardiac surgery patients; and in shock and burn victims. Additionally, ZLB Behring operates one of the world’s largest fully owned plasma collection networks. ZLB Behring is a subsidiary of CSL Limited, a biopharmaceutical company, which operates worldwide from its headquarters in Melbourne, Australia. For more information, please visit www.ZLBBehring.com.