Lilly announces update on regulatory submission timing for basal insulin peglispro

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Eli Lilly and Company (NYSE: LLY) today announced a delay in the submission of basal insulin peglispro (BIL) to regulatory agencies beyond the first quarter of 2015. The delay includes filings with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency.

Lilly will delay submission in order to generate additional clinical data to further understand and characterize the potential effects, if any, of changes in liver fat observed with BIL treatment in the Phase III trials. Lilly intends that ongoing clinical trials will continue as planned. In the clinical development program to date, in which more than 6,000 patients with type 1 and type 2 diabetes were treated for up to 18 months (approximately 3,900 patients treated with BIL), no drug-induced liver impairment or Hy’s Law cases have been observed.

“Lilly believes in the potential of BIL and its novel mechanism of action. The development of BIL remains important to us and we are committed to further evaluating the safety and efficacy of this investigational treatment for people with diabetes,” said Enrique Conterno, President, Lilly Diabetes. “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. Our priority is delivering safe and innovative medicines to meet the needs of people living with diabetes, and that’s what we aim to accomplish with this additional work.”

The length of the delay cannot be determined until clinical trial plans have been developed. However, the company anticipates the submission is likely to occur after 2016. Lilly is working to determine next steps, including potential consultations with regulators. Information regarding future submission timing will be provided following these activities.