The US Food and Drug Administration has approved dulaglutide, Eli Lilly’s once-weekly glucagon-like peptide-1 receptor agonist for type 2 diabetes, to be marketed as Trulicity.
The drug's safety and effectiveness were evaluated in six clinical trials in which 3,342 patients received Trulicity and had an improvement in their blood sugar control as observed with reductions in HbA1c. The approval does come with a boxed warning that thyroid C-cell tumours have been observed in rodent studies with Trulicity but that it is unknown whether Trulicity causes them in humans.
The FDA is also requiring post-marketing studies for Trulicity, including a trial in paediatric patients and one comparing the Lilly drug with Sanofi (insulin glargine) on glycaemic control and moderate or severe renal impairment. The agency is also asking for a cardiovascular outcomes trial.
Trulicity will go up against other GLP-1 receptor agonists, including Novo Nordisk’s Victoza (liraglutide) and AstraZeneca’s Byetta (exenatide) and its long-acting version Bydureon.