The Ozempic Revolution Is Caught

The irony undergirding the brand new wave of weight problems medication is that they initially weren’t created for weight problems in any respect. The burden loss spurred by Ozempic, a diabetes drug within the class of so-called GLP-1 agonists, gave technique to Wegovy—the identical drug, repackaged for weight problems. Zepbound, one other treatment, quickly adopted. Now these medication have a brand new objective: coronary heart Health.

On Friday, the FDA approved the use of Wegovy for decreasing the danger of coronary heart assault, stroke, and loss of life in adults who’re chubby and have heart problems. The transfer had been anticipated because the publication of a landmark trial within the fall, which confirmed the drug’s profound results on cardiovascular  Health. The choice may usher in a brand new period the place GLP-1 medication change into mainstream, opening up entry to hundreds of thousands of Individuals who beforehand didn’t qualify for Wegovy.

A number of the obstacles stopping folks from getting the drug might also start to crumble. Insurance coverage firms generally deny protection of Wegovy as a result of weight problems is seen as a beauty concern fairly than a medical one, however that argument could not maintain up for heart problems. “This new FDA indication is HUGE,” Katherine Saunders, an obesity-medicine doctor at Weill Cornell Medication, instructed me in an e mail. Wegovy could quickly be inside attain for a lot of extra Individuals—that’s, if they will discover IT.

In apply, Wegovy is maddeningly arduous to pay money for. Shortages of injectable semaglutide, the energetic ingredient in Wegovy and Ozempic, have been ongoing since March 2022; at the moment, most doses of Wegovy are in restricted provide. As the recognition of semaglutide has skyrocketed, demand has utterly outstripped the capability of its producer, Novo Nordisk. The drug is available in injection pens containing a glass vial; “these will not be simple merchandise to make,” Lars Fruergaard Jørgensen, the CEO of Novo Nordisk, mentioned in August. In response to the shortages, the corporate withheld its provide of decrease Wegovy doses final yr. As a result of remedy on the treatment should start in low doses, this meant that new sufferers who needed to start out on Wegovy functionally couldn’t. In January, the corporate started “greater than doubling the quantity of the lower-dose strengths” of the drug, a Novo Nordisk spokesperson instructed me, and IT plans to progressively improve total provide all through the remainder of the yr.

The continuing shortages have left suppliers and sufferers feeling caught. “IT is devastating to prescribe a lifesaving treatment for a affected person after which discover out IT’s not coated or we will’t find provide,” Saunders mentioned. Medical doctors are scrambling to make do with what’s out there. Ivania Rizo, an endocrinologist at Boston Medical Middle, instructed me she has needed to flip to older GLP-1 medication equivalent to Saxenda to “bridge” sufferers to greater doses of Wegovy, though now that is in shortage too. Sufferers can spend every day calling pharmacy after pharmacy seeking one with Wegovy in inventory, Rizo mentioned. In desperation, some have turned to versions of the drug which might be custom-made by compounding pharmacies with little oversight, regardless of the Information-patients-and-providers/medications-containing-semaglutide-marketed-type-2-diabetes-or-weight-loss”>FDA expressing issues about them. The pictures are speculated to be taken weekly, however others have tried to stretch their doses past that.

That the brand new FDA approval may very mainstream weight problems medication could create long-needed strain to assist resolve these shortages. IT makes clear that Wegovy is a lifesaving treatment not just for folks with weight problems but in addition for these with heart problems—the main reason behind loss of life within the U.S.—placing the impetus on Novo Nordisk to ramp up manufacturing. However within the brief time period, the entry points could persist. “The brand new approval may be very prone to worsen shortages, as a result of the demand for Wegovy will proceed to climb—now at a good sooner tempo,” Saunders mentioned.

If sufferers assume they’re caught now, they’re about to really feel entrenched. Wegovy is the one weight problems drug that has been permitted to cut back the danger of coronary heart assaults, however none of its rivals is definitely out there both. Provides of sure dosages of Eli Lilly’s Mounjaro, a diabetes drug whose energetic ingredient is offered for weight problems as Zepbound, are limited, and shortages are anticipated later this yr. “We want provide to extend dramatically,” Saunders mentioned. Each Novo Nordisk and Eli Lilly have invested closely in increasing manufacturing capability, however a few of the new vegetation gained’t open till 2029.

For all of its benefits, the FDA approval has a sobering impact on the unrelenting hype round GLP-1s. A lot of the joy round weight problems medication has centered on the long run, as dozens of pharmaceutical firms develop extra highly effective medication, and commentators think about a world with out weight problems. Within the course of, the problems of the current have gone ignored. Extra medication gained’t make a lot of a distinction if the medication themselves are out of attain.