Regulatory Decision Summary for Mylan-Perindopril Arginine

The efficacy and safety of perindopril erbumine were previously assessed when Coversyl (perindopril erbumine) was approved in Canada.

Arcosyl (perindopril arginine) from the same market authorization holder of Coversyl, Servier Canada Inc., was approved based on the demonstration of bioequivalence of perindopril arginine to perindopril erbumine. Previous review of the submission for Arcosyl demonstrated that perindopril arginine was devoid of acute toxicity after single-dose administration and was shown to be comparable to perindopril erbumine. Based on repeat-dose toxicity studies, the safety and toxicokinetic profiles were similar for both perindopril salts. No data from the preclinical studies submitted indicate that perindopril arginine could have pharmacological properties different from that of perindopril erbumine. No further safety concerns are expected for perindopril arginine.

As Arcosyl was approved, but is not marketed in Canada, it was considered acceptable for Mylan Pharmaceuticals ULC to take the same approach by performing comparative bioavailability studies against Coversyl (perindopril erbumine) to file a New Drug Submission (NDS) for Mylan-Perindopril Arginine (perindopril arginine tablets) 2.5 mg, 5 mg and 10 mg for the same indications as Coversyl.

Mylan-Perindopril Arginine (perindopril arginine) 1 x 10 mg demonstrated comparable bioavailability to Coversyl (perindopril erbumine) 1 x 8 mg for perindopril exposure under fasting conditions.

The benefit-risk profile of Mylan-Perindopril Arginine is the same as Coversyl (perindopril erbumine) marketed by Servier Canada Inc.