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Delay for submission of basal insulin peglispro to regulatory agencies announced
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A delay in the submission of basal insulin peglispro to regulatory agencies has been announced by Eli Lilly and Company, according to a press release.
The delay goes beyond the first quarter of 2015 and includes filing with the FDA and European Medicines Agency.
The delay will give Lilly a chance to generate additional clinical data in order to gain a better understanding of the effects basal insulin peglispro may have on liver fat in phase 3 trials. The clinical trials to date, which include more than 6,000 patients with type 1 and 2 diabetes, were treated for up to 18 months with no drug-induced liver impairment reported.
“Lilly believes in the potential of [basal insulin peglispro] and its novel mechanism of action,” Enrique Conterno, president of Lilly Diabetes, said in the release. “The development of [basal insulin peglispro] remains important to us, and we are committed to further evaluation 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 [basal insulin peglispro] 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.”
Until clinical trials plans have been developed, the length of the delay cannot be determine but Lilly anticipates submission to occur after 2016.