linagliptin

Linagliptin is a drug for which a variation assessment was initiated on 25 December 2023, with an opinion issued on 22 February 2024. The Marketing Authorisation application for linagliptin was submitted on 30 June 2010. The benefit-risk balance for adults is considered positive, though a negative benefit-risk balance was noted in a variation assessment.

Efficacy findings include a placebo-adjusted change from baseline HbA1c of -0.614% in adults without prior insulin and -0.409% in paediatric patients without prior insulin. In adults with prior insulin, the placebo-adjusted change was -0.647%, and in paediatric patients with prior insulin, it was -0.527%. A Bayesian analysis indicated a posterior mean placebo-corrected treatment effect for linagliptin of -0.51% for HbA1c, with a 98% posterior probability of superior efficacy. In terms of safety, the rescue therapy rate in the linagliptin + pioglitazone group was 7.9%, compared to 14.1% in the placebo + pioglitazone group, resulting in an odds ratio for rescue therapy of 0.446. The adjusted mean weight change from baseline in the linagliptin + pioglitazone group was 2.3 kg, with a treatment difference of 1.10 kg compared to placebo + pioglitazone.