Diabetes Drug Basaglar Approved By FDA As Cheaper Alternative For Lantus

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Basaglar, the diabetes drug by Eli Lilly & Co. has been approved by the US Food and Drug Administration. It is reported to be a cheaper alternative to Lantus from Sanofi AG.

According to Reuters, Basaglar comes in the form an injection or "insulin glargine," a man-made human insulin. The drug acts similarly to Lantus and is considered to be the first insulin drug with accelerated approval because the findings were based on the effects of the more expensive drug.

"The applicant demonstrated that Basaglar was sufficiently similar to Lantus to scientifically justify reliance, and also provided Basaglar-specific data to establish the drug's safety and efficacy for its approved uses. The Basaglar-specific data included two clinical trials enrolling 534 and 744 patients with type 1 and 2 diabetes mellitus respectively," the FDA stated in their release.

A statement released by the US Food and Drug Administration (FDA) states that there are about 21 million Americans that are affected by diabetes. If not managed, it can progress into serious health conditions including nerve damage, blindness, kidney damage, and heart disease. The availability of long-acting insulin products could be the key to controlling the risks of the 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 healthcare professionals and patients," said Dr. Jean-Marc Guittier, director of the Division of Metabolism and Endocrinology Products in the FDA's Center for Drug Evaluation and Research in an FDA press release.

Basaglar should only be given according to the needs of the patient. The press release adds that it is not suitable for patients who are allergic to insulin glargine or are having low blood sugar episodes. Additionally, there is a risk of contracting blood-borne pathogens from another patient if they share Basaglar KwikPens regardless if the needle has been changed.

The most common side effects for the drug include itching, rash, weight gain, fluid retention, allergic reaction, and hypoglycemia. The more serious allergic reactions to man-made insulin include shock, bronchospasm, angioedema, anaphylaxis and allergic skin reactions.

According to Yahoo, Basaglar was tentatively approved by the US agency last Aug. 18, 2014. The drug will be launched in the US in December 2016 by Eli Lilly & Co. and partner Boehringer Ingelheim once a settlement has been reached on the patent issues with Sanofi.