Delay for basal insulin peglispro in filing at FDA for Types 1 and 2 Diabetes- Eli Lilly

Eli Lilly and Company announced a delay in the submission of basal insulin peglispro (BIL) (LY 2605541) to regulatory agencies beyond the first quarter of 2015. The delay includes filings with the 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 programme 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.

Comment: Basal insulin peglispro is a once-daily alternative to Lantus (insulin glargine, also called Optisulin) from Sanofi. Liver risks (increases in liver fat) have been seen in earlier trials and now a new trial is required and this may take a year to complete. Sanofi is waiting on FDA approval for competitor Toujeo which has been filed and this is its home grown successor to Lantus. Lilly and Boehringer have EU approval and tentative US approval for Abasaglar (formerly known as Abasria), a biosimilar to Lantus.