Regulatory Decision Summary for Pronextica Liquid

Review decision

The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.

Product type:


Medicinal Ingredient(s):

Alpha1-proteinase inhibitor (human)

Control Number:


Brand/Product Name:

Pronextica Liquid

Therapeutic Area:


Type of Submission:

New Drug Submission

Decision issued:

Authorized; issued a Notice of Compliance in accordance with the Food and Drug Regulations

What was the purpose of this submission?

The purpose of this New drug submission (NDS) was to seek market authorization for Pronextica Liquid (alpha1-proteinase inhibitor [human] injection) as a chronic replacement therapy for individuals with a congenital deficiency of alpha1-proteinease inhibitor (alpha1-antitrypsin deficiency), primarily based upon cross-referencing to Prolastin-C Liquid.

Why was the decision issued?

Alpha1-proteinase inhibitor, also known as alpha1-antitrypsin (AAT), is a glycoprotein belonging to the family of serine protease inhibitors, and is a normal constituent of human blood that inhibits the activity of neutrophil elastase (NE). Excess NE is caused by AAT deficiency, a recessive hereditary metabolic disorder which results in the synthesis and secretion of defective alpha1-proteinase inhibitor. Individuals with severe AAT deficiency have limited protection against NE released during inflammation which can lead to progressive, moderate-to-severe chronic obstructive pulmonary disease (COPD) or emphysema.

Pronextica Liquid (alpha1-proteinase inhibitor [human] injection) is a therapeutic form of alpha1-proteinase inhibitor, and is an identical product to Prolastin-C Liquid (approved in 2019), with the single exception of the source of the plasma utilized in the product’s manufacturing process; Pronextica Liquid is to be produced using Canadian-sourced plasma, while Prolastin-C Liquid is currently produced with United States-sourced plasma.

As such, the clinical benefit/risk profile for Pronextica Liquid (alpha1-proteinase inhibitor [human] injection) is reliant upon the previously approved product, Prolastin-C Liquid (alpha1-proteinase inhibitor [human] injection). As supported by the anticipated clinical similarity of Pronextica Liquid and Prolastin-C Liquid, and as per the positive recommendation from the Quality review, the benefit/risk profile of Pronextica Liquid is consistent with Prolastin-C Liquid and is therefore favourable for the sought indication as a chronic replacement therapy for individuals with a congenital deficiency of alpha1- proteinase inhibitor (alpha1-antitrypsin deficiency).

The recommended dosage of Pronextica Liquid is 60 mg/kg body weight administered once weekly.

Overall, the benefit-risk profile for Pronextica Liquid (alpha1-proteinase inhibitor [human] injection) is considered to be positive as a chronic replacement therapy for individuals with a congenital deficiency of alpha1-proteinease inhibitor (alpha1-antitrypsin deficiency).

An updated Risk Management Plan (RMP) for Pronextica Liquid was reviewed by Health Canada and considered acceptable.

The chemistry and manufacturing information submitted for Pronextica Liquid has demonstrated that the drug substance and drug product can be consistently manufactured to meet the approved specifications.

Following review and requested revisions, the final labelling and Product Monograph were considered to be acceptable.

A Notice of Compliance was recommended.

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

Date of Decision:



Grifols Therapeutics LLC

Drug Identification Number(s) Issued:


Prescription status:

Schedule D drug

Date Filed: