Lilly’s Trulicity Diabetes Pen Gets EU Approval
The European Commission has approved Eli Lilly’s self-injectable diabetes drug Trulicity, a move that follows the FDA’s approval in September.
Trulicity (dulaglutide) is indicated for improving blood sugar control in combination with other medications and diet and exercise in adults with type II diabetes. It’s also indicated on its own in patients who have not succeeded with diet and exercise and cannot take metformin.
Approval was based on six Phase III trials that proved Trulicity superior to placebo and comparable or superior to other therapies, including the market leader Victoza (liraglutide), made by Novo Nordisk.
Trulicity showed similar drops in blood sugar, along with comparable tolerability, said Lilly spokeswoman Candace Johnson.
The drug comes in a pen that requires no mixing, measuring or handling of the needle. It can be taken any time of day, with or without food, and can be injected in the abdomen, thigh or upper arm, Johnson said.
Trulicity is expected to be available in Europe next year. — Lena Freund
Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.