Thousands and thousands extra People at the moment are eligible for weight problems medicine. However the injections stay maddeningly arduous to search out.
The irony undergirding the brand new wave of weight problems medicine is that they initially weren’t created for weight problems in any respect. The load loss spurred by Ozempic, a diabetes drug within the class of so-called GLP-1 agonists, gave strategy to Wegovy—the identical drug, repackaged for weight problems. Zepbound, one other treatment, quickly adopted. Now these medicine have a brand new function: coronary heart well being.
On Friday, the FDA accepted using Wegovy for decreasing the chance of coronary heart assault, stroke, and demise in adults who’re chubby and have heart problems. The transfer had been anticipated for the reason that publication of a landmark trial within the fall, which confirmed the drug’s profound results on cardiovascular well being. The choice may usher in a brand new period the place GLP-1 medicine grow to be mainstream, opening up entry to thousands and thousands of People who beforehand didn’t qualify for Wegovy.
A number of the obstacles stopping folks from getting the drug may additionally start to crumble. Insurance coverage firms generally deny protection of Wegovy as a result of weight problems is seen as a beauty concern relatively than a medical one, however that argument might not maintain up for heart problems. “This new FDA indication is HUGE,” Katherine Saunders, an obesity-medicine doctor at Weill Cornell Drugs, informed me in an e-mail. Wegovy might quickly be inside attain for a lot of extra People—that’s, if they’ll discover it.
In observe, 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 should not 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 informed me, and it plans to step by step improve total provide all through the remainder of the yr.
The continuing shortages have left suppliers and sufferers feeling caught. “It’s 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, informed me she has needed to flip to older GLP-1 medicine resembling Saxenda to “bridge” sufferers to greater doses of Wegovy, though now that’s in scarcity too. Sufferers can spend every day calling pharmacy after pharmacy looking for one with Wegovy in inventory, Rizo mentioned. In desperation, some have turned to variations of the drug which are custom-made by compounding pharmacies with little oversight, regardless of the FDA expressing issues about them. The pictures are alleged 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 medicine might create long-needed stress to assist resolve these shortages. It makes clear that Wegovy is a lifesaving treatment not just for folks with weight problems but additionally for these with heart problems—the main reason for demise within the U.S.—placing the impetus on Novo Nordisk to ramp up manufacturing. However within the quick time period, the entry points might 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 an excellent 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 accepted to cut back the chance 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 restricted, and shortages are anticipated later this yr. “We’d like 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 crops received’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 medicine has targeted on the long run, as dozens of pharmaceutical firms develop extra highly effective medicine, and commentators think about a world with out weight problems. Within the course of, the problems of the current have gone missed. Extra medicine received’t make a lot of a distinction if the medicine themselves are out of attain.