Regulatory Decision Summary for Zejula
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:
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Type of submission:
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What was the purpose of this submission?
The purpose of this Supplement to a New Drug Submission (SNDS) was to gain market authorization for a new immediate-release, film-coated tablet dosage form in a 100 mg strength pursuant to section C.08.004 of the Food and Drugs Regulations, for Zejula, submitted by GlaxoSmithKline Inc.
No new indication was proposed with this submission.
Why was the decision issued?
The formulation and manufacturing process of the new immediate-release, film-coated dosage form were selected to produce a tablet with comparable in vitro performance to that of the marketed 100 mg capsule formulation. The pivotal study (Study 3000-01-004), an open-label, randomized-sequence, multicentre, single-crossover study to assess the relative bioavailability and bioequivalence of niraparib tablet formulation compared to niraparib capsule formulation in patients with advanced solid tumours, was filed to support the new dosage form. The results of the study met the recommended standards for comparative bioavailability (i.e., the 90% confidence interval of the ratio of AUC0-72h and the relative mean Cmax were within 80.0% to 125.0%).
A food effect study was not submitted in support of the proposed tablet formulation; however, a rationale to support the lack of a food effect study was included. As a high-fat, high-calorie meal was not expected to have a clinically significant effect on the pharmacokinetics of the niraparib formulation; therefore, the lack of inclusion of a food effect study in the current submission was determined to be acceptable.
A request for waiver to perform comparative in vivo bioequivalence studies was provided for the 100 mg strength tablet. Comparative multimedia dissolution testing was provided to support the changes from the biolot (300 mg tablet) to the commercial lots (100 mg tablet). The Quality requirements of Health Canada’s Bioequivalence of Proportional Formulations policy were determined to have been met.
A complete review of the inner and outer labels, Part III Patient Medication Information section of the PM and package inserts for this new dosage form revealed that they conformed to the necessary regulatory requirements and are consistent with the labelling guidance documents.
Overall, Zejula continues to demonstrate a favourable benefit-risk profile under the proposed conditions of use.
For further details about Zejula, please refer to the Product Monograph, approved by Health Canada and available though the Drug Product Database."
Decision issued
Approved; issued a Notice of Compliance (NOC) in accordance with the Food and Drug Regulations.
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| ZEJULA | 02530031 | GLAXOSMITHKLINE INC | NIRAPARIB (NIRAPARIB TOSYLATE) 100 MG |