The FDA on Wednesday approved Eli Lilly's Basaglar (insulin glargine) for use in improving glycaemic control in children and adults with type 1 diabetes and adults with type 2 diabetes, marking the first approval of an insulin product through the FDA's 505(b)(2) regulatory pathway. The therapy, which was developed as part of an alliance with Boehringer Ingelheim, was awarded tentative approval by the FDA in August 2014.
Jean-Marc Guettier, director of the Division of Metabolism and Endocrinology Products in the FDA's Center for Drug Evaluation and Research, remarked "long-acting insulin products like insulin glargine play an important role in the treatment of types 1 and 2 diabetes mellitus, and today's approval is expected to expand the availability of treatment options for health care professionals and patients." The FDA noted that the safety and efficacy of the therapy were supported by the findings of two clinical studies involving 534 and 744 patients with type 1 and type 2 diabetes mellitus, respectively.
In September, Sanofi and Eli Lilly reached an agreement settling a US patent infringement lawsuit concerning patents covering the French drugmaker's diabetes therapy Lantus SoloSTAR (insulin glargine). Eli Lilly noted that Basaglar has "an identical amino acid sequence to Lantus" and is delivered via the prefilled KwikPen. The therapy was previously approved by regulators in Europe, where it is marketed under the name Abasria, as a biosimilar of Lantus.
Eli Lilly indicated that Basaglar will be available in the US starting on December 15, 2016. Company spokesman Greg Kueterman said Eli Lilly has not set a price for the drug, although he noted it will be cheaper than Lantus. Sanofi's product generated global sales of over $8 billion last year.
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