FDA Approves First Generic of Daily GLP-1 Diabetes Injection

The headquarters of the U.S. Food and Drug Administration in Silver Spring, Md., on Nov. 4, 2009. Jason Reed/Reuters

The U.S. Food and Drug Administration (FDA) has approved the first generic version of a daily injectable GLP-1 medication for patients aged 10 and older with Type 2 diabetes.

The medication, a lower-cost alternative to the brand-name drug Victoza, or liraglutide, aims to improve blood sugar control when used alongside diet and exercise. The approval was granted to Hikma Pharmaceuticals, a British company.

The FDA approved the drug as certain GLP-1 medications, including liraglutide, face ongoing shortages. The generic version is expected to expand access for patients managing diabetes, which affects more than 38 million Americans, according to federal health data.

Dr. Iilun Murphy, director of the FDA’s Office of Generic Drugs, said the FDA supports the development of generic drugs, such as GLP-1s, by funding research and informing industry through guidance.

“Generic drugs provide additional treatment options which are generally more affordable for patients,” he said in a statement. “Today’s approval underscores the FDA’s continued commitment to advancing patient access to safe, effective and high-quality generic drug products.”

Type 2 diabetes, the most common form of the disease, is deemed a chronic condition that develops when the body struggles to use insulin effectively, leading to high blood sugar levels. While it is most common in adults, it is increasingly being diagnosed in children and teens.

Safety Warnings and Risks

The FDA detailed a number of risks associated with liraglutide that will be included as warnings on the box.

These include an increased chance of thyroid C-cell tumors. Patients with a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome Type 2 should not use the medication.

The drug is also linked to serious complications such as pancreatitis, which involves inflammation of the pancreas and can be life-threatening. Patients with kidney problems should use caution, as the medication can lead to renal impairment or kidney failure.

Additionally, cases of gallbladder disease, including gallstones and inflammation, have been reported.

Liraglutide can also cause dangerously low blood sugar levels, particularly when used with insulin or other medications that lower blood sugar.

Hypersensitivity reactions are another concern, making the drug unsuitable for individuals with known allergies to liraglutide or its components.

The FDA also advises against sharing liraglutide pens, even with a new needle, due to the risk of transmitting infections.

Common side effects observed during clinical trials include nausea, diarrhea, vomiting, decreased appetite, indigestion, and constipation. While these symptoms are often mild, they may persist for some patients, the FDA said.

Addressing a National Challenge

During National Diabetes Month in October, the White House said diabetes takes a significant physical and financial toll on Americans.

Insulin, a life-saving drug for some with diabetes, has historically cost upwards of $300 per vial, forcing some patients to ration their medication. The White House has moved to lower these costs, including capping insulin prices at $35 per month for Medicare recipients under the Inflation Reduction Act.

“Since I came into office, I have worked to ensure that health care is a right in this country, not a privilege—and that meant lowering the cost of insulin,” President Joe Biden said in October.

Type 2 diabetes is the most common form of diabetes and develops when the body struggles to use insulin effectively to regulate blood sugar levels.

Medications like liraglutide mimic a hormone in the pancreas to help regulate blood sugar levels, making them a critical component of diabetes management.