The Food and Drug Administration on Tuesday approved Ozempic to reduce the risk of serious complications in people who have both Type 2 diabetes and chronic kidney disease.
Type 2 diabetes is a leading cause of chronic kidney disease, which affects more than one in seven U.S. adults. The medication can lower the chance that patients with both conditions will undergo worsening kidney disease, kidney failure and death from cardiovascular issues.
“Over the last 20 years, it’s been an area where researchers tried hard but delivered very little,” said Dr. Stephen Gough, senior vice president of global medical affairs at Novo Nordisk, the company that makes Ozempic. “To have something new like this is really exciting, and offers promise to patients,” he said.
Ozempic is already approved to treat Type 2 diabetes and to lower the risk of major cardiovascular events in adults with diabetes and a history of heart disease. The F.D.A. based its decision to expand the approved uses of Ozempic on research showing that people with Type 2 diabetes and chronic kidney disease who took the drug had a 24 percent lower likelihood of experiencing a complication, like requiring dialysis or a transplant, compared to people who took a placebo. They also had slower rates of kidney decline and were less likely to die from cardiovascular problems.
“The more we can delay the decline in kidney function, the better,” said Dr. Melanie Hoenig, a nephrologist at Beth Israel Deaconess Medical Center in Boston. Dr. Hoenig said she already prescribes Ozempic to some of her patients.
Doctors have long expressed frustration with just how few options there are for treatment. Many patients take medications to lower blood pressure, blood sugar and cholesterol, which tend to be elevated in people with chronic kidney disease. Patients also sometimes take drugs to alleviate swelling that occurs when the kidneys can’t properly filter fluid, as well as medications to manage iron, calcium and vitamin D levels.
Doctors also routinely encourage lifestyle changes, including diet and exercise modifications, in part because these can help manage Type 2 diabetes. High blood sugar can damage blood vessels in the kidneys, preventing them from filtering waste out of blood. Roughly 40 percent of people with Type 2 diabetes will develop chronic kidney disease, Dr. Gough said.
It isn’t clear exactly how Ozempic might benefit the kidneys beyond managing diabetes. Researchers have theorized that Ozempic reduces inflammation throughout the body, including the kidneys. That could help explain why the medication and similar drugs are proving to be so useful for a range of chronic conditions, including cardiovascular issues. The drugs do come with side effects, most commonly gastrointestinal issues like nausea, vomiting and stomach pain.
The approval means that doctors will now be able to prescribe the drug specifically for chronic kidney disease in diabetic patients, and insurance companies will face more pressure to cover Ozempic.
As more people seek out Ozempic, though, Novo Nordisk has struggled to keep up with demand. The F.D.A. lists semaglutide, the compound in Ozempic and the weight loss drug Wegovy, as currently in shortage.
“Many people, unfortunately, cannot get it,” Dr. Hoenig said. “But if they can and it works for them, and they can tolerate it, it’s a wonderful thing to have more tools.”
