Lilly pulls plug on basal insulin Peglispro
pharmafile | December 8, 2015 | News story | Manufacturing and Production | R&D, basal insulin peglispro, diabetes, lilly, peglispro, phase III failure
Lilly has decided to pull out of filing its diabetes drug basal insulin peglispro, after failing to convince regulators and experts that there are no liver safety concerns linked to the new drug.
The US firm says it will cease development of basal insulin peglispro (BIL), which the company had seen as a potential treatment for type 1 and type 2 diabetes. Instead Lilly will “focus its research and development efforts on other assets in its portfolio and pipeline.”
In February Lilly it said would delay its plans to submit the drug for assessment by regulators, after changes in liver fat were observed in patients in the company’s Phase III IMAGINE trials. At the time the company said it “was delaying regulatory submission in order to better understand and characterise 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.”
Lilly insists that there were no cases of drug-induced liver impairment in the trials, of more than 6,000 patients with type 1 and type 2 diabetes treated for up to 18 months – approximately 3,900 of whom were treated with BIL.
Despite this, and after presumably being given discouraging feedback from “regulatory authorities and other external experts,” the company has decided to stop the drug’s clinical development program. BIL, a novel insulin discovered and developed in Lilly Research Laboratories, was being studied as a once-daily treatment for type 1 and type 2 diabetes.
In a statement, Lilly says: “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 – and not by any new safety signals – and was ultimately driven by the decision to focus research and development efforts on other potential treatments.
And Enrique Conterno, president of Lilly Diabetes, says: “While we are encouraged by the efficacy data we observed for BIL, we know that moving forward would have required a significant amount of time and investment with no assurance that we would find conclusive answer.
“We are disappointed in the outcome for BIL, but we have an unprecedented opportunity to build upon the industry’s broadest diabetes portfolio, which includes six new treatments approved since the middle of 2014. Lilly remains fully committed to innovative research in the diabetes space, including insulins, as we strive to make life better for people around the world.”
The decision to discontinue development of BIL will hit the company’s bottom line. Lilly says scrapping the trials and the regulatory filings is expected to cost £55 million in research and development costs.
Lilian Anekwe
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