Sanofi’s Once-Daily Diabetes Drug Wins FDA Approval

The US Food and Drug Administration (FDA) has approved Sanofi’s once-daily diabetes drug, Adlyxin (lixisenatide). The injection is designed to help adult patients with type 2 diabetes maintain healthy blood sugar levels.

Sanofi waited years to get approval for the diabetes drug, with the FDA asking for additional information on the cardiovascular safety of the treatment. Despite the long approval process, the US has now joined more than 60 other countries which have allowed the drug to enter onto the market.

“The FDA continues to support the development of new drug therapies for diabetes management,” said Dr. Mary Thanh Hai Parks, deputy director, Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research. “Adlyxin will add to the available treatment options to control blood sugar levels for those with type 2.”

Sanofi had originally planned to submit their application to the FDA in 2013, however their plans were put on hold when the agency asked for additional safety studies to be performed. In September of 2015, the company was finally ready to resubmit to the FDA after a 6,000-patient clinical trial cleared up any cardiovascular concerns. Since the drug has been widely-approved in countries across the EU, Sanofi took advantage of the two-year delay by collecting real-world dosing information for the injectable.

“The approval of Adlyxin reaffirms our continued commitment to addressing the challenges faced by people living with diabetes when trying to reach and maintain their individual blood glucose (HbA1c) targets,” said Peter Guenter, Executive Vice President, Head, Global Diabetes & Cardiovascular Business Unit, Sanofi. “We are pleased with this approval, as it offers us the opportunity to continue helping patients treated with basal insulin who remain uncontrolled.”

The new diabetes drug is now a direct competitor to Novo Nordisk’s Victoza (liraglutide) and Lilly’s Trulicity (dulaglutide). Adlyxin is designed to reduce blood sugar levels and increase glucose-dependent insulin secretion by the pancreas.

Victoza pulled in $2.64 billion in sales in 2015, representing an 18 percent increase over the previous year. Sanofi’s Adlyxin is to be used in conjunction with diet and exercise to treat type 2 diabetes.