Eli Lilly and Company, a global healthcare leader, and Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI), the largest US subsidiary of Boehringer Ingelheim Corporation, announced that the US Food and Drug Administration (FDA) granted approval for Basaglar (insulin glargine injection) 100 units/ml. 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 Basaglar FDA approval is based, in part, upon an extensive clinical development programme. 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 US- and non-US-approved Lantus.
The FDA approval follows Basaglar's tentative US approval in August 2014, which was contingent upon patent litigation resolution. As per the settlement agreement with Sanofi, Basaglar will be available in the US 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 US 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.
The most common side effects of Basaglar include low blood sugar (hypoglycemia), allergic reactions, including reactions at the injection site, skin thickening or pits at the injection site (lipodystrophy).
Approximately 29 million Americans and an estimated 415 million people worldwide have type 1 or type 2 diabetes. Type 2 diabetes is the most common type, accounting for an estimated 90 to 95 per cent of all diabetes cases. Diabetes is a chronic condition that occurs when the body either does not properly produce, or use, the hormone insulin.