FDA approval of new obesity drug ‘a step forward’ but challenges remain

CHICAGO --- Northwestern University medical and health economist experts are available to speak to media in response to today’s news that the U.S. Food and Drug Administration has approved Eli Lilly and Company’s obesity-management drug tirzepatide (sold as Zepbound).

While the approval of the drug marks a “step forward,” getting this class of drugs to the right patients who need them continues to be the challenge, the experts say. Additionally, the cost of the drugs and the current supply shortage could exacerbate health disparities. Lastly, there can be dangerous side effects for people who don’t need to be taking them, the experts say.

“It was approved for the treatment of obesity or overweight with weight-related medical problems; it was not approved for weight loss,” said Northwestern Medicine physician Dr. Robert Kushner, who co-authored a study on tirzepatide that was published last month in Nature Medicine. “We are trying to change the conversation around obesity to get away from just weight loss.”

The experts:

• Health economist Lindsay Allen, assistant professor of emergency medicine at the Buehler Center for Health Policy and Economics at Northwestern University Feinberg School of Medicine.
• Northwestern Medicine preventive cardiologist Sadiya Khan, the Magerstadt Professor of Cardiovascular Epidemiology and associate professor of medicine (cardiology) and preventive medicine (epidemiology) at Feinberg.
• Robert Kushner, professor of medicine (endocrinology and medical education) at Feinberg.
• Northwestern Medicine cardiologist Sanjiv J. Shah is the Neil J. Stone professor of cardiology at Feinberg and director of the Institute for Artificial Intelligence in Medicine’s Center for Deep Phenotyping and Precision Therapeutics.

Contact Kristin Samuelson at ksamuelson@northwestern.edu to arrange an interview with the experts.

‘A step forward’

Lindsay Allen: “The approval of Zepbound for weight loss is a significant milestone, yet it intensifies the pressure on an already strained supply chain,” Allen said. “Despite efforts by manufacturers to boost production, the reality is that we're likely to face persistent shortages. The ramp-up in supply is a step forward, but it may not fully bridge the gap between supply and soaring demand.”

Dr. Sadiya Khan: “The FDA approval of Zepbound adds a new option to our toolbox for treating patients living with obesity. We’ve already seen prescriptions for Zepbound skyrocket in recent months since it’s been available for clinical use, and this approval represents a critical step forward to help our patients live longer, healthier lives. 

“These drugs that target weight loss reinforce the important message that obesity is a disease, and treatments such as these can be life changing and lifesaving. In fact, a recent trial that focused on patients with heart failure with preserved ejection fraction (STEP-HFpEF) showed quality of life and ability to walk longer distances improved significantly with semaglutide.”

Dr. Sanjiv Shah: “We didn’t have the evidence that obesity drugs are beneficial in patients with heart failure until recently, with the publication of our STEP-HFpEF trial. We still need data from additional trials to know just how efficacious these drugs are in patients with heart failure, but the early results are very promising.

“It’s possible that these drugs have a beneficial effect directly on the heart, but I think the majority of the benefits we’re seeing are due to the significant amount of weight loss induced by these medications. It sounds trivial but it’s not: There is a large body of evidence that obesity can cause heart failure, so it’s gratifying to see that treating obesity results in improving many aspects of health, including reducing symptoms, increasing exercise capacity, and improving blood levels of markers of heart failure.”

Exacerbating health disparities

Allen: “The shortage of these weight-management drugs could disproportionately impact those who are less affluent. With many health plans not covering obesity treatments, this could exacerbate health disparities, leaving lower-income individuals more vulnerable to obesity and its associated health complications.

“It bears repeating that the long-term effects of these medications are still unknown. They are costly, and the possibility that patients might need to maintain lifelong treatment to manage their weight adds a significant financial burden to consider.”

Khan: “The cost of this new agent and other GLP1-RA therapies continue to be a critical barrier and raises concerns that these advances will come at a cost of exacerbating health inequities because those who are most likely to need these therapies may have the least access.”

Serious side effects

Khan: “While these drugs can be beneficial, there can also be serious side effects. These drugs may be dangerous for people who don’t need them, due to serious side effects. That’s why working with your doctor to make sure people need it and can safely take it is important.”