Regulatory, Results

Eli Lilly steers URLi toward the FDA after scoring positive results in a pair of PhIII diabetes trials

Eli Lilly’s lucrative diabetes franchise got a needed boost on Tuesday when the company reported a follow-on candidate to its blockbuster insulin product Humalog was found to be as effective in controlling glucose levels in a pair of late-stage clinical trials.

Lilly said that two Phase III studies showed the new product, Ultra Rapid Lispro (URLi), work as well as Humalog. The company plans to file for regulatory approval in 2019. Both URLi and Humalog are rapid-acting insulins.

Humalog is still Lilly’s top-selling product, with 2017 sales of $2.8 billion. But increased pricing pressures in the marketplace have been taking a toll, with 2017 numbers coming in 5% lower than those in the previous year. The product lost patent protection in 2014.

Adding to Lilly’s woes is the FDA’s push to increase marketplace competition by speeding up the approval of generic or “follow on” products, especially for such high demand therapies as insulin. More products in the marketplace also give insurers more leverage in negotiating product discounts and rebates. The insulin market is currently dominated by Lilly, Sanofi and Novo Nordisk.

In December, Sanofi won approval for a Humalog rival, a rapid-acting insulin lispro product called Admelog.

“Despite progress in insulin and diabetes management, many people with diabetes find controlling high blood sugar levels after meals frustrating. If approved, URLi will be a new option in mealtime insulin therapy designed to help keep blood sugar in range after eating,” said Thomas Hardy, senior medical director, insulins product development, Lilly Diabetes.


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