Glucagon-like peptide-1 receptor agonists (GLP-1RAs) represent a type 2 diabetes (T2D) injectable drug class that is increasingly prescribed to patients on oral anti-diabetic treatments who are struggling to get their blood glucose levels under control.

As the GLP-1RA space becomes increasingly crowded, there is always the risk that new entrants might fall through the cracks and be unable to acquire sufficient patient share within the GLP-1RA space. This was the case for GlaxoSmithKline’s (GSK’s) Tanzeum/Eperzan (albiglutide). Despite convenient once-weekly administration and encouraging cardiovascular (CV) benefits revealed in the Harmony outcomes study, Tanzeum has already been discontinued as of July 2018 for economic reasons.

Tanzeum was approved and launched in the US and Europe in 2014, as a once-weekly injectable drug, and as such, it was expected to steal patient share from AstraZeneca’s twice-daily Byetta and Novo Nordisk’s once-daily Victoza, both of which are from the same class of GLP-1RAs. Despite this, Tanzeum experienced sluggish sales, mainly due to competition from Eli Lilly’s newly launched once-weekly GLP-1RA, Trulicity. Additionally, sales of Tanzeum suffered as a result of complaints from patients and physicians alike concerning incorrect administration of Trulicity by patients, due to complex instructions and preparation.

The HARMONY outcomes study assessed the CV safety of Tanzeum in T2D patients with CV disease. At the 54th EASD annual meeting in Berlin, the results of the study were discussed at length. The trial was a randomised, double-blind, placebo-controlled study that followed 9,463 T2D patients. Patients who received Tanzeum treatment experienced a 22% reduction in the primary outcome (first occurrence of CV death, myocardial infarction, or stroke, compared to placebo). This statistically significant risk reduction of the primary composite outcome has once again brought the GLP-1RA class into the spotlight, emphasising the overall CV benefits now associated with the class.

Regardless of the commercial failure of Tanzeum, insight from the HARMONY outcomes study is helpful when considering the broad treatment implications of the GLP-1RA class as a whole. In addition to the HARMONY outcomes trial, there have been multiple studies investigating GLP-1RAs to determine their CV safety profiles. Although each GLP-1RA is unique, the HARMONY outcomes study has provided critical information to the understanding of GLP-1RA CV safety. Considering Tanzeum’s flop, GlobalData believes that in order to be competitive within the GLP-1RA space, incoming agents will have to confer CV benefit, while also incorporating superior administration convenience compared to incumbent once-weekly agents.

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