The US Food and Drug Administration has announced it has granted approval to administer Basaglar (insulin glargine injection), a long-acting human insulin analog in order to improve glycemic control in adult and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. It is the first insulin product approved through an abbreviated approval pathway under the Federal Food, Drug, and Cosmetic Act. A 505(b)(2) application was submitted for Basaglar that relied, in part, on the FDA’s finding of safety and effectiveness for Lantus (insulin glargine injection). The Basaglar-specific data included two clinical trials enrolling 534 and 744 patients with type 1 and 2 diabetes mellitus respectively.
According to the Centers for Disease Control and Prevention, approximately 21 million people in the United States have been diagnosed with diabetes, although it is unknown how many more may have the disease without being aware of it. Over time, diabetes increases the risk of serious health complications, including disease, blindness, and nerve and kidney damage. Improvement in blood sugar control can reduce the risk of some of these long-term complications.
“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,” remarked Dr. Jean-Marc Guettier, M.D., director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research.
Basaglar is administered subcutaneously once daily at any time of day, but at the same time every day. It was also noted that dosing of Basaglar should be “Individualized based on the patient’s needs. At the same the FDA warns that Basaglar should not be used during episodes of hypoglycemia (low blood sugar) or in patients with hypersensitivity to insulin glargine or one of its ingredients. Basaglar KwikPens must never be shared between patients, even if the needle is changed. Sharing poses a risk for transmission of blood-borne pathogens.
Patients or caregivers should monitor blood glucose in all patients treated with insulin products. Insulin regimens should be modified cautiously and only under medical supervision. Basaglar may cause low blood sugar (hypoglycemia), which can be life-threatening. Patients should be monitored more closely with changes to insulin dosage, co-administration of other glucose-lowering medications, meal pattern, and physical activity and in patients with renal impairment or hepatic impairment or hypoglycemia unawareness.
Severe, life threatening, generalized allergic reactions, including anaphylaxis, or generalized skin reactions, angioedema, bronchospasm, hypotension and shock may occur with any insulin.
The most common adverse reactions associated with Basaglar in clinical trials were hypoglycemia, allergic reactions, injection site reactions, pitting at the injection site (lipodystrophy), itching, rash, edema (fluid retention) and weight gain.
Note: Although Eli Lilly, which manufactures Basaglar was granted approval, it will not be allowed to launch the product until Dec. 15, 2016, under terms of settlement regarding a U.S. patent infringement lawsuit over Lilly’s pursuit of regulatory approval for a product that would compete with Sanofi’s Lantus SoloSTAR. Sanofi and Lilly agreed to end that lawsuit and to discontinue similar disputes worldwide. According to terms of the agreement, Lilly will pay royalties to Sanofi in exchange for a license to certain Sanofi patents.