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The FDA Approves Weight Loss Drug Zepbound, a Wegovy and Ozempic Rival

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The blockbuster weight reduction drug Wegovy has a brand new rival. Right now, the US Meals and Drug Administration approved a new drug for weight management referred to as Zepbound, made by American pharmaceutical firm Eli Lilly.

The weekly injectable drug is supposed for adults who’re obese or overweight and have at the very least one weight-related situation, corresponding to hypertension, kind 2 diabetes, or excessive ldl cholesterol. The lively ingredient in Zepbound, tirzepatide, is already approved under the brand name Mounjaro to assist enhance blood sugar in adults with kind 2 diabetes and is widely prescribed off-label for weight loss.

Zepbound and Mounjaro are much like the better-known Wegovy and Ozempic, that are each manufactured by Danish firm Novo Nordisk. All of those medication mimic a naturally occurring hormone within the physique referred to as GLP-1. Produced within the intestine, GLP-1 lowers blood sugar, slows the emptying of the abdomen, and regulates urge for food. Zepbound and Mounjaro additionally act on an identical hormone referred to as GIP to cut back meals consumption.

GLP-1 medication have been initially developed to treat type 2 diabetes however are more and more getting used for weight reduction. (Wegovy is indicated for weight administration and Ozempic for diabetes, though it may be prescribed off-label for weight administration as nicely.) Roughly 70 p.c of American adults have weight problems or are obese, and lots of of those that are obese have a weight-related well being situation.

Due to rising demand for these medication, Ozempic and Wegovy have been on the FDA’s drug shortage list since March 2022. With demand outstripping manufacturing, Novo Nordisk has tried to restrict the variety of new individuals who can begin taking Wegovy. The drug is available in preloaded injector pens containing completely different doses, and sufferers should begin out with a low-dose pen earlier than steadily stepping as much as larger doses. The drugmaker is restricting supply of those low-dose injections so it could actually concentrate on serving present sufferers as it really works to spice up manufacturing capability.

With the FDA’s approval of Zepbound, folks searching for to shed extra pounds now have another choice. Like Ozempic and Wegovy, it’s also began at a low dose and steadily elevated.

Zepbound’s approval was based mostly on trials run by Eli Lilly that included 2,539 adults with weight problems or extra weight and weight-related medical issues apart from diabetes, according to the company. In these research, folks taking Zepbound who additionally made weight-reduction plan and train modifications skilled substantial weight reduction at 72 weeks in contrast with these on a placebo. On the highest dose of 15 milligrams, folks taking Zepbound misplaced a mean of 48 kilos. On the lowest dose of 5 milligrams, folks misplaced a mean of 34. These taking a placebo misplaced seven kilos on common.

One in three sufferers taking Zepbound on the highest dose misplaced over 58 kilos, or 25 p.c of their physique weight, in comparison with 1.5 p.c on placebo, in response to Eli Lilly. The typical beginning weight of the volunteers within the trial was 231 kilos.

Some folks taking Zepbound reported gastrointestinal reactions, together with nausea, diarrhea, vomiting, constipation, or belly ache, in response to the corporate.

In a statement, Eli Lilly representatives wrote that Zepbound is predicted to be out there within the US by the top of the yr at an inventory value of $1,059.87 per 30 days. Wegovy costs about $1,349 a month with out insurance coverage. Although insurance coverage sometimes covers the price of diabetes remedies, it might not cowl medication for weight administration. Eli Lilly’s announcement says the corporate is placing a industrial financial savings card program in place to assist individuals who might profit from Zepbound entry it.

Drugmakers are already engaged on pill versions of GLP-1 drugs, which may make them much more engaging to sufferers. And with new information anticipated to be unveiled at this weekend’s American Coronary heart Affiliation assembly on the cardiovascular benefits of those medication, demand may surge much more.

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