Millions more Americans are now eligible to receive obesity drugs. However, syringes are still very difficult to find.
The irony behind the new wave of obesity drugs is that they weren’t originally designed for obesity at all. The weight loss promoted by the diabetes drug Ozempic, a class of so-called GLP-1 agonists, has been replaced by Wegoby, a repackaged version of the same drug for obesity. Another drug, Zepbound, soon followed. Now, these drugs have a new purpose: heart health.
On Friday, the F.D.A. Authorized to use Wegovy Reduces the risk of heart attack, stroke, and death in adults who are overweight and have cardiovascular disease. The move had been expected since a landmark trial was published in the fall that showed the drug had a significant impact on cardiovascular health. The decision could usher in a new era in which GLP-1 drugs become mainstream and open access to millions of Americans who were previously ineligible for Wegovy.
Some of the barriers that prevent people from getting drugs may also begin to crumble. Insurance companies typically deny coverage for Wegovy because obesity is considered a cosmetic concern rather than a medical problem, but that argument may not apply to cardiovascular disease. “This new FDA indication is huge,” Katherine Sanders, a bariatric physician at Weill Cornell Medicine, told me in her email. Wegovy may soon be within reach for even more Americans, if they can find it.
In fact, Wegovy is horribly difficult to obtain. Shortages of injectable semaglutide, the active ingredient in Wigovy and Ozempic, have persisted ever since. March 2022;Currently, most doses of Wegovy are in limited supply. As semaglutide’s popularity soared, demand completely exceeded the production capacity of its manufacturer, Novo Nordisk.medicine comes in injection pen Contains a glass vial. “It’s not easy to make these products,” Nordisk CEO Lars Fluergaard Jorgensen said in August. In response to the shortage, the company withheld supplies of lower doses of Wegovy last year. Because treatment with the drug must be started at a low dose, this meant that new patients who wanted to start receiving Wegovy were functionally unable to do so. A Novo Nordisk spokesperson said the company began “more than doubling the amount of the drug’s low-dose potent ingredient” in January and plans to gradually increase overall supply throughout the remainder of this year. It is said that
Continued shortages are leaving healthcare workers and patients at a standstill. “It’s devastating when you prescribe a life-saving drug to a patient and it’s not covered by insurance or you can’t find a source,” Sanders said. Doctors are scrambling to cope with what’s available. Ivania Rizzo, an endocrinologist at Boston Medical Center, said that in the past, patients had to rely on older GLP-1 drugs such as Saxenda. “bridge” Patients are being given higher doses of Wegovy; is missing Too. Rizzo said patients will be calling pharmacies every day to find one that has Wegovy in stock. Some have become desperate. drug version Yet they are custom-made by compounding pharmacies with little oversight. FDA expresses concern About them. Injections are supposed to be given weekly, but some people are trying to extend the doses beyond that.
The potential for new FDA approvals to mainstream obesity drugs could create long-needed pressure to address these shortages. This demonstrates that Wegoby is a lifesaving drug not only for obese patients, but also for patients with cardiovascular disease, the leading cause of death in the United States, and provides momentum for Nordisk’s production expansion. However, access issues may persist in the short term. “The new approvals are very likely to worsen the shortage as demand for Wegobee continues to grow, and at an even faster pace,” Saunders said.
If patients think they’re stuck, that’s exactly where they feel stuck. Wegovy is the only obesity drug approved to reduce the risk of heart attacks, but no competing drugs are readily available. The supply of specific doses of Eli Lilly’s Mounjaro, a diabetes drug whose active ingredient is sold as an obesity treatment as Zepbound, will limitedand shortage It is scheduled for later this year. “We need to dramatically increase supply,” Sanders said.both novo nordisk and Eli Lilly has invested heavily in expanding production capacity, but some new plants are not scheduled to start operating until 2029.
The FDA approval, for all its benefits, has a sobering effect on the constant hype surrounding GLP-1. Much of the excitement surrounding obesity drugs focuses on the future, as dozens of drug companies develop more powerful drugs and commentators imagine a world without obesity. In the process, current issues have been overlooked. There is little point in increasing the amount of medicine if the medicine itself is out of reach.
