Eli Lilly and Company and Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) were granted approval by the U.S. Food and Drug Administration (FDA) for Basaglar (insulin glargine injection) 100 units/mL.
In a press release on Wednesday, the companies explained that Basaglar is a long-acting insulin with an identical amino acid sequence to Lantus, another U-100 insulin glargine. It is delivered via the prefilled Basaglar KwikPen.
Basaglar is indicated to control high blood sugar in adults and children with type 1 diabetes and adults with type 2 diabetes. Basaglar should not be used to treat diabetic ketoacidosis. Basaglar should not be used during episodes of low blood sugar (hypoglycemia) or in people with an allergy to insulin glargine or any of the ingredients in Basaglar.
“Lilly has a long history of developing and manufacturing insulin, having introduced the world’s first commercial insulin more than 90 years ago,” said David Kendall, MD, vice president, Global Medical Affairs, Lilly Diabetes. “Basaglar will be a welcome addition to our insulin and alliance portfolios, offering an option for people with diabetes who may need a long-acting insulin.”
The company explained that Basaglar FDA approval is based, in part, upon an extensive clinical development program. The submission included results from pharmacokinetic and pharmacodynamic studies, as well as Phase III studies in people with type 1 and type 2 diabetes comparing the safety and efficacy of Basaglar to U.S.- and non-U.S.-approved Lantus.
The FDA approval follows Basaglar’stentative U.S. approval in August 2014, which was contingent upon patent litigation resolution. Per the settlement agreement with Sanofi, Basaglar will be available in the U.S. starting on December 15, 2016.
“The Basaglar FDA approval marks the first insulin therapy to be approved in the U.S. as part of our alliance with Lilly and broadens our portfolio of treatment options for people with type 1 and type 2 diabetes,” said Paul Fonteyne, president and CEO, BIPI. “We remain committed to the care of people with diabetes and look forward to a successful U.S. launch of Basaglar.”
This latest regulatory approval is the 11th for Basaglar worldwide, with launches taking place in several countries this year, including under the trade name Abasaglar in Europe.