FDA Approves First Generic Glucagon for Hypoglycemia

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FDA Approves First Generic Glucagon for Hypoglycemia

For people with diabetes who use insulin or other drugs that can cause hypoglycemia (low blood glucose), avoiding episodes of dangerously low glucose is a major consideration in managing your diabetes. But sometimes the unexpected happens, and despite your best efforts, your glucose level plummets. If this happens quickly enough that you can’t reverse it by taking glucose orally, you’ll need to receive a glucagon injection.

Emergency glucagon works by quickly causing the release of stored glucose from your liver. While it’s generally very effective — as long as you haven’t received it recently — glucagon kits tend to be expensive, especially if they’re not covered by health insurance.

But the decision of the U.S .Food and Drug Administration (FDA) to approve a new, generic form of glucagon may usher in increased competition that brings down the cost of this potentially lifesaving drug.

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A synthetic hormone to reverse low glucose

As noted in an FDA press release announcing the agency’s decision, the newly approved version of glucagon — like the others already on the market — is a synthetic form of the natural human hormone. It’s packaged as a 1-milligram vial as part of an emergency kit, with instructions on how to administer the drug in critical situations. Each emergency kit can be used only once.

“Glucagon for injection has been approved for use in the U.S. for more than 20 years, but until today, there has been no approved generic of this important drug,” says Sally Choe, PhD, director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research, in the press release. “Today’s approval reflects the FDA’s continued commitment to advancing patient access to lower-cost, high-quality generic drug products that are as safe and effective as their brand-name counterparts.”

Choe notes that supporting the development of generic alternatives to complex drugs like glucagon has been a major focus of the FDA’s efforts to lower drug prices. Because these drugs are traditionally difficult to manufacture, they often lack generic alternatives — much more so than small-molecule drugs that aren’t based on much larger human hormones. The FDA prioritizes the review of generic drug applications when fewer than three generic versions of a drug are already approved, and there is no active patent protection for the original drug.

Shortened approval process, but strong safety standards

Unlike for a completely new drug, an application for a generic version of an existing drug doesn’t have to go through the full process of clinical trials to establish safety and effectiveness. This helps keep the cost of drug development down, ensuring that as many safe generic alternatives make it to the market. But the FDA still has standards in place to ensure safety and effectiveness.

In general, applications for generic versions of drugs must include data that show two things: that the active ingredient in the drug is the same as in the existing version, and that it’s safe and effective for at least one already approved drug indication. Glucagon is already approved not just for emergency treatment of hypoglycemia, but also as a diagnostic aid for radiologic examination of the gastrointestinal (GI) tract, since glucagon reduces intestinal motility (the ability to move).

Glucagon should only be used for severe cases of hypoglycemia, when a person’s glucose level drops so much that they become confused or unconscious, or experience other symptoms that make it necessary for another person to assist in their treatment. Common side effects of glucagon injection include nausea and vomiting, an increased heart rate, and redness or swelling at the injection site.

The new approval for generic glucagon was granted to Amphastar Pharmaceuticals, Inc., based in Rancho Cucamonga, California.

Want to learn more about glucagon? Read “Using a Glucagon Kit” and “Severe Hypoglycemia and Glucagon.”

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