- Eli Lilly has been forced to delay regulatory filings for its in-development long-acting insulin (despite positive phase 3 data) based on evidence of liver toxicity. That will delay FDA review of the candidate by at least two years—and potentially scuttle it altogether.
- Based on phase 3 data from the last year, peglispro leads to a statistically significant increase in liver fat.
- Even if the program survives, peglispro will most likely be preceded to market by Sanofi's Toujeo and Novo's Tresiba, both long-acting insulins.
It's a huge setback. But Lilly's public response to it so far is a master class in communications. In a comment to FierceBiotech, Lily Diabetes President Enrique Conterno explained, "While we are disappointed with the delay, we feel it is important to gain a better understanding of the potential effects of (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."
Lilly's efforts to shore up its diabetes franchise have not been entirely unproductive. In September 2014, the FDA approved Trulicity, Lilly's once-weekly GLP-1 diabetes treatment. It was subsequently approved in the EU in November 2014. Analysts predict revenues as high as $1.3 billion in the next five years.
Around the same time, Lilly, in partnership with Boehringer Ingelheim, made history when Basaglar, the biosimilar version of Sanofi's long-acting insulin Lantus, became the first EMA-approved biosimilar insulin. Basaglar received tentative regulatory approval in the U.S. in June 2014, but there are still patent issues pending.