Vokanamet(canagliflozin)

Vokanamet (canagliflozin) is a drug with strengths of 150 mg / 1000 mg. The Marketing Authorisation Application for Vokanamet was submitted on 4 March 2013, following a Centralised procedure eligibility agreement date of 17 November 2011. Scientific advice was sought on 19 March 2009, 22 October 2009, and 21 October 2010. The procedure started on 27 March 2013, and the Marketing Authorisation Date was 15 November 2013.

Clinical trials evaluated Vokanamet's efficacy, showing a reduction in HbA1c from baseline by -0.57% and -0.70%. The proportion of subjects achieving HbA1c <7.0% ranged from 28.0% to 58.5%. Body weight percent change from baseline was observed at -2.3% and -3.0%. Relative to placebo, HbA1c reduction was -1.16% and -0.91%. Systolic Blood Pressure (SBP) reduction from baseline was -3.34 mmHg and -5.04 mmHg, while Diastolic Blood Pressure (DBP) reduction from baseline was -1.67 mmHg and -2.14 mmHg. The placebo arm showed an SBP change from baseline of 0.38 mmHg.

Safety data included 24-month exposure for CANA Total at 679 and Non-CANA at 307. The rate of discontinuation ranged from 11% to 17%. A significant proportion of subjects, 73%, had metformin in their therapy regimen, with total numbers of subjects with metformin at baseline ranging from 2392 to 5151 across different studies.