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

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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. Today, the US Food 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, akin to hypertension, sort 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 sort 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 the same hormone referred to as GIP to cut back meals consumption.

GLP-1 medication had 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.) Approximately 70 % of American adults have weight problems or are obese, and lots of of those that are obese have a weight-related well being situation.

Thanks 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 step by step stepping as much as larger doses. The drugmaker is restricting supply of those low-dose injections so it will possibly deal with serving present sufferers as it really works to spice up manufacturing capability.

With the FDA’s approval of Zepbound, individuals looking for to reduce weight now have another choice. Like Ozempic and Wegovy, additionally it is began at a low dose and step by step elevated.

Zepbound’s approval was primarily based on trials run by Eli Lilly that included 2,539 adults with weight problems or extra weight and weight-related medical issues aside from diabetes, according to the company. In these research, individuals taking Zepbound who additionally made weight-reduction plan and train adjustments skilled substantial weight reduction at 72 weeks in contrast with these on a placebo. At the very best dose of 15 milligrams, individuals taking Zepbound misplaced a median of 48 kilos. At the bottom dose of 5 milligrams, individuals misplaced a median of 34. Those taking a placebo misplaced seven kilos on common.

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

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

In a statement, Eli Lilly representatives wrote that Zepbound is predicted to be accessible within the US by the tip of the 12 months at an inventory worth of $1,059.87 monthly. Wegovy costs about $1,349 a month with out insurance coverage. Though insurance coverage sometimes covers the price of diabetes therapies, it could 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 enticing to sufferers. And with new knowledge anticipated to be unveiled at this weekend’s American Heart Association assembly on the cardiovascular benefits of those medication, demand may surge much more.

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