Eli Lilly and Company will delay the submission of regulatory filings for approval of basal insulin peglispro (BIL) to beyond the first quarter of 2015. The delay includes filings with the US 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 said that 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.

Source: Eli Lilly and Company