{"id":44549,"date":"2015-12-17T00:00:00","date_gmt":"2015-12-17T05:00:00","guid":{"rendered":"https:\/\/asweetlife.org\/fda-approves-basaglar-lilly-boehringer-ingelheim-new-long-acting-insulin-2\/"},"modified":"2016-09-25T04:42:59","modified_gmt":"2016-09-25T08:42:59","slug":"fda-approves-basaglar-lilly-boehringer-ingelheim-new-long-acting-insulin-2","status":"publish","type":"post","link":"https:\/\/asweetlife.org\/?p=44549","title":{"rendered":"FDA Approves\u00a0Basaglar,\u00a0Lilly-Boehringer Ingelheim New Long Acting Insulin"},"content":{"rendered":"

\"Lilly-Boehringer<\/a>The U.S. FDA approved Basaglar (insulin glargine injection),\u00a0the newest diabetes treatment from the Lilly-Boehringer Ingelheim diabetes alliance.<\/p>\n

Basaglar is\u00a0a long-acting human insulin analog\u00a0which is used to\u00a0improve glycemic control in adult and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.\u00a0<\/span><\/p>\n

\u201cLong-acting insulin products like insulin glargine play an important role in the treatment of types 1 and 2 diabetes mellitus, and today\u2019s approval is expected to expand the availability of treatment options for health care professionals and patients,\u201d said Jean-Marc Guettier, M.D., director of the Division of Metabolism and Endocrinology Products in the FDA\u2019s Center for Drug Evaluation and Research.<\/span><\/p>\n

Basaglar 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\u2019s finding of safety and effectiveness f<\/span>or\u00a0Lantus (insulin glargine injection)\u00a0to support approval. The applicant demonstrated that Basaglar was sufficiently similar to Lantus to scientifically justify reliance, and also provided Basaglar-specific data to establish the drug\u2019s safety and efficacy for its approved uses. The Basaglar-specific data included two clinical trials enrolling 534 and 7<\/span>44 patients with type 1 and 2 diabetes mellitus respectively.\u00a0<\/span><\/p>\n

Dosing of Basaglar should be individualized based on the patient\u2019s needs. Basaglar is administered subcutaneously once daily at any time of day, but at the same time every day.<\/span><\/p>\n

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.<\/span><\/p>\n

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\u00a0may 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, physical activity and in patients with renal impairment or hepatic impairment or\u00a0hypoglycemia\u00a0unawareness.<\/span><\/p>\n

Severe, life-threatening, generalized allergic reactions, including anaphylaxis, or generalized skin reactions, angioedema, bronchospasm, hypotension and shock may occur with any insulin.<\/span><\/p>\n

The most common adverse reactions associated with Basaglar in clinical trials were hypoglycemia, allergic reactions, injection site reactions,\u00a0pitting at the injection site (lipodystrophy), itching, rash, edema (fluid retention) and weight gain.<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"

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