Eli Lilly Plans Regulatory Filing for Basal Insulin Peglispro in 2015
Eli Lilly and Company’s plans to file for marketing authorization with US Food and Drug Administration and the European Medicines Agency regulatory for a new basal insulin, insulin peglispro, by the end of the first quarter of 2015. Basal insulins include intermediate-acting and longer-acting insulins. These start lowering blood sugar more slowly and last longer than faster-acting insulins.
Lilly announced the decision following favorable Phase III results in treating Type I and Type II diabetes in lowering hemoglobin A1c compared with insulin glargine, the active ingredient in Sanofi’s basal insulin product, Lantus. Lantus is Sanofi’s top-selling drug with 2013 revenues of EUR 5.7 billion ($7.4 billion).
Basal insulin peglispro, which was discovered and developed in Lilly Research Laboratories, is currently in Phase III clinical trials and is among several diabetes molecules in the company’s late-stage pipeline. It is being studied as a once-daily treatment for Type 1 and Type 2 diabetes.
Source: Eli Lilly