Eli Lilly And Co (NYSE:LLY) Won’t Seek Regulatory Approval For Its Insulin Over Next Two Years
Eli Lilly and Co (NYSE:LLY) is going to delay the regulatory filing for its basil insulin lispro, BIL or LY2605541, as it needs to explore whether changes in liver fat observed during Phase III trials are a cause for concern. The company is considering generating additional clinical data to explore the finding. The company confirmed that it will file for approval of BIL later than its initial schedule of the first quarter of the current year or as late as 2016.
The announcement underscores the back stepping of Eli Lilly from toppling rival firm Sanofi SA (ADR) (NYSE:SNY)’s Lantus. The delay would be a major blow for the company, already having Phase III data demonstrating BIL reduces HbA1c levels better than Sanofi’s Lantus. HbA1c, haemoglobin A1c, is a marker of glucose control. Lantus has generated nearly $7 billion in its global annual sales.
Enrique Conterno, President of Lilly Diabetes, expressed that it is important to gain a better insight of the potential effects of BIL on the liver before regulatory filing for the drugs approval. Conterno acknowledged that the delay is disappointing and also mentioned that the company’s priority is to deliver safe and innovative products to address the needs of patients living with diabetes.
The key concern for Eli Lilly and Co (NYSE:LLY) is the fatty changes, indicating a direct toxic effect of BIL. However, the company explains that no evidence of liver damage has been seen in 3,900 patients treated with BIL in clinical trials so far.
The delay would also puut a dent into the company’s plan to compete into Lantus’ market share as the entry of emerging molecules would further strife the competition. While Sanofi is developing Toujeo, a bio-similar version of Lantus; Merck & Co., Inc. (NYSE:MRK) and Samsung Bioepis have already submitted their product for regulatory review.
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