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Lilly Abandons Diabetes Treatment
Eli Lilly and Company has announced that it will halt development of basal insulin peglispro (BIL), a potential treatment for type-1 and type-2 diabetes.
In February, the company reported that it was delaying regulatory submission in order to better understand and characterize the potential effects, if any, of changes in liver fat observed with BIL treatment compared with insulin glargine treatment in the phase 3 IMAGINE trials. No drug-induced liver impairment or Hy’s Law cases were observed in the IMAGINE clinical development program of more than 6,000 patients with type-1 or type-2 diabetes treated for up to 18 months (approximately 3,900 patients treated with BIL).
Over the past several months, Lilly engaged with regulatory authorities and other external experts to assess potential development plans for BIL that could provide additional clarity on the liver-fat data observed in the IMAGINE trials. The decision to stop the program was informed by these conversations.
BIL was being studied as a once-daily treatment for type-1 and type-2 diabetes. BIL is a hepato-preferential basal insulin. Its activity profile is derived from its reduced effect in peripheral tissue, making it more similar to endogenous insulin compared with other exogenous insulins with a conventional activity profile.
Source: Eli Lilly; December 4, 2015.