Tag: Diabetes

CNN
 — 

Ozempic, the blockbuster GLP-1 drug that was originally approved to treat type 2 diabetes, has now also been approved by the US Food and Drug Administration to reduce certain risks associated with chronic kidney disease, drugmaker Novo Nordisk said Tuesday.

A Phase 3 clinical trial found that injections of the semaglutide medication once weekly reduced the risk of kidney disease worsening by 24% in people who also had diabetes. It also reduced the risk of kidney failure and cut the risk of death from heart disease by about 5% in adults with both type 2 diabetes and chronic kidney disease, the company said in a news release.

Chronic kidney disease is a common complication for people living with type 2 diabetes. Diabetes is the leading cause of kidney failure, which is one of the leading causes of death in the US and worldwide; about a third of adults with diabetes also have chronic kidney disease, according to the US Centers for Disease Control and Prevention

The clinical trial tested the efficacy of Ozempic when added to the standard of care, not as a replacement for other treatments for disease management such as medicines to manage blood pressure, including ACE inhibitors and ARBs. About 3,500 adults across 28 countries were enrolled in the trial, which started in 2019 and followed participants for an average of about 3½ years.

The new indications, approved Tuesday by the FDA, make Ozempic the most broadly indicated drug in its class, with the largest set of specific medical conditions that it may be prescribed to treat.

Novo Nordisk is conducting a different study to understand how and why semgalutide seems to reduce the progression of kidney disease, said Stephen Gough, global chief medical officer and senior vice president at Novo Nordisk. But even though scientists don’t fully understand the mechanisms behind them, the positive effects are strong: The clinical study was stopped early after reaching positive endpoints sooner than expected, and no new safety risks were identified in this trial, he said.

“This really means something to the patients,” Gough told CNN. “The impact on not just kidney disease but also cardiovascular disease and on all-cause death.”

Ozempic and other semaglutide injections such as Wegovy have been in short supply for years due to their rapid popularity. The FDA now lists Ozempic as “available,” but there is still high demand.

“This is a medicine that’s already available, both in diabetes clinics and now in renal clinics, so I would hope the uptake would start pretty quickly,” Gough said, adding that he hopes the confidence that comes with the data behind this approval will aid clinicians who are making daily decisions about how and when to use different treatments.

“It does help clinicians with their decision-making process, and it helps them focus those medicines to the patients who will benefit the most,” he said.