The decision will further broaden the use of the blockbuster drug.
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.