Better Health, Brighter Future
CAMBRIDGE, Massachusetts, March 11, 2025 – Takeda (TSE:4502/NYSE:TAK) today announced the U.S. Food and Drug Administration (FDA) has approved an update to the GLASSIA® (Alpha-1 Proteinase Inhibitor [Human]) U.S. Prescribing Information, which now includes 1-, 4- and 5-gram single-dose vial sizes. The 1-gram vial size of GLASSIA was originally approved in 2010. The new larger vial sizes will be available beginning July 2025 to help streamline the GLASSIA infusion experience for patients who previously needed four or more 1-gram vials per infusion, due to its weight-based dosing instructions. The availability of larger vial sizes also has the potential to reduce waste and maximize storage efficiencies for customers and for patients who self-infuse. With four infusion setting options, GLASSIA is the only ready-to-use liquid treatment for appropriate patients with alpha-1 antitrypsin deficiency (alpha-1) approved for self-administration after receiving training.1
“The availability of GLASSIA in 4- and 5-gram vials demonstrates our continued commitment to improving the treatment experience for the alpha-1 community.” said Rick Ascroft, senior vice president and head of the U.S. Plasma-Derived Therapies Business Unit. “For patients who self-infuse at home, with proper training, this has the potential to reduce steps in the preparation and administration process, requiring fewer vials and supplies for infusions.”
At least 100,000 people in the U.S. have alpha-1, and more than 90% don’t know they have it.2,3,4,5 People with severe hereditary alpha-1 have low or absent serum levels of the protective protein in their blood and lungs, which places them at risk for early-onset chronic obstructive pulmonary disease (COPD), emphysema or liver disease.6,7 Alpha-1 is a genetic (inherited) condition, which means it runs in families.6
GLASSIA is an Alpha1-Proteinase Inhibitor (Human) (Alpha1-PI) indicated for chronic augmentation and maintenance therapy in adults with clinically evident emphysema due to severe hereditary deficiency of Alpha1-PI (alpha1-antitrypsin 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 conclusively 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.
Contraindications
Warnings and Precautions
Hypersensitivity: GLASSIA may contain trace amounts of IgA. Monitor vital signs continuously and observe the patient throughout the infusion. If hypersensitivity symptoms occur, discontinue the infusion and administer appropriate emergency treatment. Have epinephrine and/or other appropriate supportive therapy available for any acute anaphylactic or anaphylactoid reaction.
Transmissible Infectious Agents: Because GLASSIA is made from human plasma it may carry a risk of transmitting infectious agents such as viruses, the variant Creutzfeldt-Jakob disease (vCJD) and theoretically, the Creutzfeldt-Jakob disease (CJD) agent and other pathogens. No seroconversions for hepatitis B or C or human immunodeficiency virus or any other known infectious agent were reported with the use of GLASSIA during the clinical trials.
Adverse Reactions
The serious adverse reaction observed during clinical trials with GLASSIA was exacerbation of chronic obstructive pulmonary disease (COPD).
The most common adverse reactions during clinical trials were headache and upper respiratory infection.
Please click for GLASSIA Full Prescribing Information.
Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com.
Taryn Corbino
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