One of Eli Lilly and Co.’s experimental diabetes drugs was as effective at lowering blood sugar levels as the leading drug on the market, according to results of a study announced Tuesday by Lilly.
The Indianapolis-based drugmaker said its drug dulaglutide showed “non-inferiority” when tested against the strongest dose of Victoza, a best-selling drug for Type 2 diabetics made by Denmark-based Novo Nordisk A/S.
The study of 599 patients examined the effect on hemoglobin A1c scores, a measure of diabetes control.
Lilly said it would wait to disclose detailed results of its Phase 3 clinical trial of the two drugs until scientific meetings later this year. But the result is good news for Lilly, which is counting on dulaglutide and a few other drugs it plans to launch this year to rejuvenate its sales after the patent expiration in December of its top-selling drug, Cymbalta.
Before the latest study, Wall Street analysts predicted dulaglutide could achieve $1.5 billion a year in sales. Victoza generated $2.07 billion in 2013 sales for Novo Nordisk, according to data compiled by Bloomberg, and was the top seller in its class.
Dulaglutide has already proved itself superior to other diabetes drugs, including metformin, Byetta and Januvia, in clinicial studies announced last year.
But showing itself as good as Victoza should help Lilly secure better pricing from health insurers and state-run health plans.
“An approvable product is no longer the finish line for the industry. It’s a reimbursable product,” Mark Cziraky, vice president of research at HealthCore, a subsidiary of Indianapolis-based WellPoint Inc., told IBJ last year.
Dulaglutide is part of Lilly’s strategy to have a medication in every major class of therapy for diabetics. The company plans to use that portfolio to offer doctors a broad spectrum of treatments as well as to negotiate deals with health insurers and pharmacy managers.
“Options that allow patients to more easily use the treatment are, we believe, important,” said Sherry Martin, Lilly’s senior medical director, who oversaw the drug’s late-stage clinical trial.
Dulaglutide has been submitted to U.S. regulators for approval, with a decision expected by September. It would be the only once-a-week injection that doesn’t also require patients to prepare the dose, as AstraZeneca Plc’s Bydureon does.
In Lilly’s study, patients were given either 1.5 weekly milligrams of dulaglutide or 1.8 daily milligrams of Victoza, and their A1c scores were followed over 26 weeks. Lilly said that side effects were similar for both groups.
Both dulaglutide and Victoza are part of a class called GLP-1 receptor agonists. They tell the body to make more insulin when needed, as well as reduce the body’s sugar production.
About 25.8 million people in the U.S. have diabetes, or almost 8 percent of the population, according to the American Diabetes Association. The Type 2 form of the illness occurs when the body loses its natural ability to control sugar using insulin produced by the pancreas. It can be caused by obesity.