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Lilly delays filing of Lantus rival on safety concerns

Concerns over changes in liver fat detected in phase III trials

Eli Lilly HQ 

Eli Lilly has reined in plans to topple Sanofi's Lantus from the head of the long-acting insulin market after delaying regulatory filings for its insulin peglispro in the EU and US.

Lilly has said it needs to explore whether "changes in liver" fat seen in phase III trials of the drug are a cause for concern and intends to "generate additional clinical data" to explore the finding.

Lilly has said it will now file for approval of basil insulin lispro (BIL), also known by the code LY2605541, later than its initial schedule of the first quarter of this year and possibly as late as 2016.

The key concern for Lilly is the fatty changes seen in the trials may indicate a direct toxic effect of BIL, although the company said no evidence of damage to the liver have been seen in 3,900 patients treated with the drug to date in clinical trials.

"No drug-induced liver impairment or Hy's Law cases have been observed," it said, referring to a well-established assessment of clinical biomarkers, drawn up by US physician Hy Zimmerman in the last century to distinguish between drug-induced liver injury and damage caused by other factors such as viral hepatitis, alcohol damage or reduced blood flow to the organ.

The delay is a major blow for Lilly, which has phase III data in hand showing that insulin peglispro is able to reduce levels of haemoglobin A1c (HbA1c) - a marker of glucose control - better than Lantus (insulin glargine), a $7bn-a-year blockbuster.

The window of opportunity for the company to make inroads into Lantus' market share was always going to be short given emerging competition from Novo Nordisk's long-acting rival Tresiba (insulin degludec) as well as biosimilar versions of Sanofi's drug.

Lilly and Boehringer already have one Lantus biosimilar approved in Europe, while another from Merck & Co and Samsung Bioepis is under review. Meanwhile, Sanofi is also developing a Lantus follow-up called Toujeo which is already under regulatory review in both the US and Europe.

Bernstein analyst fears the worst, suggesting that there is a "high likelihood" that the problems for the drug are terminal from "a regulatory standpoint and/or a commercial standpoint."

"While we are disappointed with the delay, we feel it is important to gain a better understanding of the potential effects of BIL on the liver before asking regulators to review the drug for approval," commented Enrique Conterno, president of Lilly Diabetes.

"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."

Article by
Phil Taylor

24th February 2015

From: Research, Sales

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