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news.The US Food and Drug Administration (FDA) has offered tentative approval for Basaglar insulin glargine injection, which is jointly developed by Eli Lilly and Boehringer Ingelheim, signifying its compliance with all the regulatory needs for approval.
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However, the final approval of the new injection has been kept on hold until the end of the 30-month period in mid-2016, as per the Drug Price Competition and Patent Term Restoration Act ("Hatch Waxman"), following a patent infringement suit by Sanofi.
Lilly Diabetes president Enrique Conterno said: "The tentative approval for Basaglar is another step toward providing an important option for people with diabetes in the U.S. who need basal insulin treatment.
"We believe insulin glargine will continue to be used widely for many years, and Lilly and Boehringer Ingelheim are committed to addressing the needs of people living with diabetes and providing support beyond the medicine."
Mainly aimed at improving glycemic control in adults with type 2 diabetes and alongside mealtime insulin in adults and pediatric patients with type 1 diabetes, Basaglar offers long-lasting blood sugar control amid meals and during the night.
Basaglar integrates similar amino acid sequence as of the insulin glargine product and had been tentatively permitted for use with pre-filled dosing device KwikPen.
Basaglar has been contraindicated during events of hypoglycemia and in patients with hypersensitivity to insulin glargine or one of its other elements.
Boehringer Ingelheim Pharmaceuticals metabolic-clinical development and medical affairs vice president Christophe Arbet-Engels said:
"Because of the combined diabetes, development and commercialization experience of Lilly and Boehringer Ingelheim, we are confident that Basaglar, upon final approval, will become a valuable treatment choice for people who need a basal insulin to manage their type 1 or type 2 diabetes."