Eli Lilly and Company recently announced a delay in the compliance of basal insulin peglispro (BIL) with regulatory agencies, pushing the product back later than the 1st quarter of 2015. This delay includes filings with both the United States Food and Drug Administration (FDA) and the European Medicines Agency.
Lilly has chosen to delay the submissions so it can generate more clinical data to better understand and describe the potential effects and alterations in liver fat that treatment with BIL in Phase III trials might cause. Lilly expects the clinical trials currently being conducted will proceed as planned. The clinical advancement program to date involves more than 6,000 type 1 and type 2 diabetes patients; these patients received treatment for up to eighteen months (almost 3,900 patients received treatment with BIL), and there were no observed cases of drug-induced liver impairment or Hy’s Law conditions.
“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. 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,” said Lilly Diabetes’ Enrique Conterno.
The length of the delay will remain undetermined until the clinical trial goals have been established. Nevertheless, the company predicts that the submission is more likely to happen after 2016. Lilly is making efforts to define its future steps, including potential consultations with regulators. Data concerning the future submission’s timing will be communicated following these activities.
Eli Lilly and Company is a global healthcare company that brings together caring with discovery to improve the lives of billions of people around the world. The company was founded more than one hundred years ago.