Regulatory Decision Summary for Glassia

This New Drug Submission was filed to seek market authorization for Glassia (Alpha-1 Proteinase Inhibitor) for the following indication:

Glassia (Alpha-1 Proteinase Inhibitor [Alpha-PI]) is indicated for chronic augmentation and maintenance therapy in adults with clinically evident emphysema due to severe hereditary deficiency of Alpha1-PI, also known as alpha-1-antitrypsin deficiency (AATD). Glassia increases antigenic and functional (anti-neutrophil elastase capacity [ANEC]) serum levels.

Glassia was studied in three clinical trials. The benefit of Glassia was demonstrated in Study API-002, which was a phase 2/3, randomized, double-blind, controlled study in patients with evident lung disease related to alpha-1 antitrypsin deficiency. The results showed that Glassia is not inferior to Prolastin, another drug used for treatment of this condition.

Glassia was also studied in a phase 1, single dose, pharmacokinetic study (Study API-001) in subjects with congenital alpha-1 proteinase inhibitor (Alpha-1 PI) deficiency. In addition, a phase 4 study (Study 471201) was conducted in healthy subjects to evaluate the tolerability of different intravenous infusion rates of Glassia.

Glassia was well tolerated in healthy subjects (Study 471201) and in patients with Alpha1-PI deficiency (Study API-001 and Study API-002). The most commonly reported drug adverse reaction was headache. No seroconversions for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) were observed. Viral nucleic acid amplification testing (NAT) testing was only performed in Study 471210. All NAT results for HIV-1, HBV, HCV, and Parvovirus were negative 14 days post last dose of Glassia.

In addition, the plasma source material used for Glassia is obtained under contract from Baxalta US Inc. Donor suitability screening and plasma handling procedures are compliant with United States regulatory requirements. Testing for viral markers is carried out using United States Food and Drugs Administration (FDA) approved test kits or methodologies. Furthermore, Glassia undergoes two viral clearance steps, solvent/detergent treatment and nanofiltration, during the manufacturing process.

Based on the evaluation of the data submitted, the benefit/risk profile of Glassia in adults with clinically evident lung disease due to severe hereditary alpha1 antitrypsin deficiency is considered acceptable.

For further details about Glassia, please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.