Lyxumia plus basal insulin lowers blood sugar, latest data show

French pharma major Sanofi (Euronext: SAN) has announced new GetGoal-L sub-analysis results showing that reductions in HbA1c with Lyxumia (lixisenatide), when added to basal insulin, were greatest in patients with type 2 diabetes who had well-controlled baseline fasting plasma glucose (FPG).

These findings, presented at the 49th annual meeting of the European Association for the Study of Diabetes in Barcelona, Spain, are consistent with the efficacy profile of Lyxumia, which shows a clinical and statistically significant reduction in HbA1c across different patient populations. The results also showed that reductions in body weight with Lyxumia, when added to basal insulin, were greatest in this group.

Drug already approved in EU and Japan

Lyxumia, which gained European and Japanese marketing approval earlier this year (The Pharma Letter February 4 and June 28), was in-licensed from Denmark-based Zealand Pharma (Nasdaq OMX Copenhagen: ZEAL). Last month, Sanofi withdrew its New Drug Application in the USA, citing fears that the Food and Drug Administration’s review of the Evaluation of Lixisenatide in Acute Coronary Syndrome (ELIXA) study would compromise the integrity of this large ongoing cardiovascular outcomes trial (TPL September 12).