First Liquid Ready-to-Use Alpha1-Proteinase Inhibitor Will Expand Treatment Options for Specialists Treating AAT Deficiency Patients
DEERFIELD, Ill. October 25, 2010 - Baxter International Inc. (NYSE: BAX) today announced the commercial launch of GLASSIATM [Alpha1-Proteinase Inhibitor (Human)] in the United States. GLASSIATM is the first available ready-to-use liquid alpha1-proteinase inhibitor (Alpha1-PI) and is indicated as a chronic augmentation and maintenance therapy in adults with emphysema due to congenital deficiency of alpha-1 antitrypsin (AAT), an under-diagnosed hereditary condition characterized by a low level of alpha-1 protein in the blood.
"We welcome the availability of new therapies that give clinicians more convenient options when choosing AAT deficiency augmentation therapies for their patients," said John Walsh, president of the U.S. Alpha-1 Foundation.
GLASSIATM, which was approved by the FDA on July 9, 2010, is administered once a week and works by augmenting the levels of AAT in the blood and lungs. Through a definitive agreement with Kamada Ltd., Baxter is the exclusive distributor for GLASSIATM in the United States and other select markets.
In addition to providing biological therapeutics for the disorder, Baxter is also working to improve awareness and early diagnosis of AAT deficiency. The company sponsors the AlphaTest® kit to make it easy for physicians to test patients through a simple finger stick. To date, Baxter has helped screen more than 85,000 people for AAT deficiency.
"Baxter's commitment to the Alpha-1 community is 3-fold; raising awareness, screening and detection, and bringing new innovative therapeutic options to patients and healthcare professionals," said John Shannon, Vice President and General Manager of Baxter BioScience's U.S. Biopharmaceuticals business. "With the introduction of GLASSIATM, specialists now have the convenience of a ready-to-use liquid presentation that can be administered without reconstitution."
About AAT Deficiency
Alpha-1 antitrypsin deficiency is a hereditary condition characterized by a low level of alpha-1 protein in the blood and the lungs. This naturally occurring protein helps protect lung tissue from damaging enzymes that are released by white blood cells. The most common symptoms of AAT deficiency include shortness of breath and cough. This disorder may result in early onset emphysema and severe lung damage.
The American Lung Association estimates that 100,000 people in the United States have the disorder, though under-diagnosis remains a persistent issue, as fewer than 10 percent of those living with AAT deficiency have been properly diagnosed. The American Thoracic Society/European Respiratory Society Standards recommend that all patients with Chronic Obstructive Pulmonary Disease (COPD) be tested once for the disorder.
GLASSIA is indicated for chronic augmentation and maintenance therapy in individuals with emphysema due to congenital deficiency of alpha1-proteinase inhibitor (Alpha1-PI), also known as alpha1-antitrypsin (AAT) deficiency.
- The effect of augmentation therapy with GLASSIA or any Alpha1-PI product on pulmonary exacerbations and on the progression of emphysema in Alpha1-PI deficiency has not been demonstrated in randomized, controlled clinical trials.
- Clinical data demonstrating the long term effects of chronic augmentation and maintenance therapy of individuals with GLASSIA are not available.
- GLASSIA is not indicated as therapy for lung disease in patients in whom severe Alpha1-PI deficiency has not been established.
Important Risk Information for GLASSIATM
GLASSIA is contraindicated in IgA deficient patients with antibodies against IgA. GLASSIA is contraindicated in individuals with a history of severe immediate hypersensitivity reactions, including anaphylaxis, to Alpha1-PI products.
GLASSIA is made from human plasma. It may carry a risk of transmitting infectious agents, such as viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
GLASSIA should be administered at room temperature at a rate not greater than 0.04 mL/kg body weight per minute. If anaphylactic or severe anaphylactoid reactions occur, the infusion should be discontinued immediately.
Safety and effectiveness in patients over 65 years of age have not been established.
Two serious adverse reactions observed on two separate occasions during clinical studies with GLASSIA were cholangitis and exacerbation of chronic obstructive pulmonary disease (COPD).
The most common product-related adverse reactions in clinical studies were headache and dizziness.
For full prescribing information, please visit: http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/
Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.
Baxter is a registered trademark of Baxter International Inc.
Glassia is a trademark of Kamada Ltd.