Grifols launches new vial sizes of PROLASTIN, the alpha1 antitrypsin (AAT) augmentation therapy most prescribed worldwide

Barcelona, Spain, Feb. 5, 2024 – Grifols (MCE: GRF, MCE: GRF.P NASDAQ: GRFS), one of the world’s leading producers of plasma-derived medicines, today announced it has introduced 4- and 5-gram vials of PROLASTIN (alpha₁-proteinase inhibitor [human]) used for long-term alpha₁ antitrypsin (AAT) augmentation therapy in patients with severe alpha₁-antitrypsin deficiency (alpha-1) who show evidence of progressive lung disease.

Alpha-1 is an underdiagnosed² genetic disorder that occurs when a patient has low levels of AAT, a protective protein that safeguards the lungs. With an excellent safety record³, PROLASTIN augments patients' levels of the AAT protein through intravenous administration, making the alpha₁-proteinase inhibitor dose immediately available in the patient’s bloodstream.

Strengthening Grifols’ PROLASTIN brand portfolio, the new 4- and 5-gram vials will enable healthcare professionals to meet the dosing needs of patients more easily, all while using less packaging waste throughout the process and reducing storage space. The currently approved dosage of PROLASTIN is 60 mg/kg in weekly infusions. Previously the vials were only available in a 1-gram dose.

“For over 35 years, PROLASTIN has always been trusted by health care professionals. The new vial options will better enable healthcare professionals to tailor treatment and enhance the patient experience,” said Joana Sabat, SVP Biopharma Launch Unit. “Grifols continues to build on its strong commitment to the alpha-1 community through new solutions that make the management of alpha-1 easier.”

The PROLASTIN^® 4- and 5-gram vials will be available in Germany and Denmark in February, before being rolled out to other European markets during 2024.

About alpha₁-antitrypsin deficiency (alpha-1)

Alpha-1 is a rare hereditary disease defined by a deficiency or absence of the alpha₁ antitrypsin protein in plasma. It is the most common cause of severe pulmonary emphysema and chronic obstructive pulmonary disease (COPD) in adults, as well as the most common cause of liver disease in children.

This illness is more prevalent than other rare lung diseases such as cystic fibrosis and pulmonary arterial hypertension. Alpha-1 symptoms vary depending on the degree of severity and type of genetic mutation, as well as external factors.

Alpha-1 affects some 3.4 million people around the world. Ninety percent of individuals remain undiagnosed with severe alpha-1, even though a simple screening test will quickly detect the condition.

For more information about alpha-1, please visit: www.alpha1.org.

About PROLASTIN

PROLASTIN is indicated for long-term augmentation therapy in patients with severe alpha₁-proteinase inhibitor deficiency (phenotypes PiZZ, PiZ [null], Pi [null,null] and PiSZ). Patients are to be under optimal pharmacologic and non-pharmacologic treatment and show evidence of progressive lung disease (e.g. lower forced expiratory volume per second (FEV₁) predicted, impaired walking capacity or increased number of exacerbations) as evaluated by a healthcare professional experienced in the treatment of alpha₁-proteinase inhibitor deficiency.⁴

¹Includes Prolastin^®, Prolastina^®, Prolastin^®-C and Prolastin^®-C Liquid.
²American Thoracic Society; European Respiratory Society. American Thoracic Society/European Respiratory Society statement: standards for the diagnosis and management of individuals with alpha-1 antitrypsin deficiency. Am J Respir Crit Care Med. 2003;168(7):818-900. doi:10.1164/rccm.168.7.818.
³STOCKS, J. M. et al. Pharmacokinetic comparability of Prolastin^®-C to Prolastin^® in alpha₁-antitrypsin deficiency: a randomized study. BMC clinical pharmacology, [s. l.], v. 10, p. 13, 2010.
⁴Grifols. PROLASTIN^® Summary of Product Characteristics. Accessed February 2024.