Eli Lilly is delaying submissions on both sides of the Atlantic for its experimental diabetes therapy basal insulin peglispro (BIL), to allow for collection of extra data intended to cement the drug’s safety profile.
The US healthcare giant said it wants to generate additional clinical data to “further understand and characterise” the potential effects of changes in liver fat seen with BIL treatment in Phase III trials.
“While we are disappointed with the delay, we feel it is important to gain a better understanding of the potential effects of BIL on the liver before asking regulators to review the drug for approval,” said Enrique Conterno, President of Lilly Diabetes, explaining the decision.
The length of delay cannot be determined until clinical plans have been developed, but the firm said at this stage it does not expect to file the drug until after 2016. Lilly had originally planned to file BIL during the first quarter of this year.