On June 4, 2021, the FDA introduced the long-anticipated approval of Wegovy, an injectable medicine taken as soon as per week for weight administration.
Wegovy obtained important media consideration within the months previous approval, with a New York Instances article declaring it a “sport changer,” MedPage At this time reporting its “unprecedented outcomes,” and the BBC asserting it may mark a “new period” in treating weight problems. Ongoing media protection continues to extol the efficacy of Wegovy as higher than some other medicine at the moment in the marketplace for weight administration. Such sensational headlines are commonplace within the media, so we should ask ourselves: is all of the media consideration actually warranted?
What’s Wegovy and the way does it work?
Wegovy is the model title for the high-dose injectable peptide hormone molecule referred to as semaglutide, a medicine that was beforehand authorized by the FDA beneath the model names Rybelsus (oral) and Ozempic (lower-dose injection) for the remedy of sort 2 diabetes. Injectable semaglutide eliminates the strict tips for ingesting on an empty abdomen required by oral semaglutide, whereas the higher-dose Wegovy permits for higher crossing of the blood-brain barrier, which will increase its weight-loss efficacy.
Semaglutide is in a category of medicines referred to as glucagon-like peptide-1 receptor agonists, or GLP-1 RAs. GLP-1 is a hormone naturally launched within the gastrointestinal tract in response to nutrient consumption. It has a number of results, together with growing insulin launch from the pancreas, slowing down abdomen emptying, and concentrating on receptors within the mind that trigger urge for food discount. This ends in a sensation of satiety, or fullness, lasting for much longer than potential with pure GLP-1 hormone ranges.
Who can take Wegovy?
Wegovy, like all different prescription drugs designated for the remedy of weight problems, is authorized to be used in these with a physique mass index (BMI) of 30 kg/m2 or larger, or these with a BMI of 27 kg/m2 with a weight-related medical situation corresponding to hypertension, sort 2 diabetes, or excessive ldl cholesterol.
What are the dangers and advantages of Wegovy?
Part 3 medical trials of Wegovy, dubbed the STEP (Semaglutide Therapy Impact in Folks with Weight problems) trials, have been performed in quite a lot of medical eventualities, every various barely within the research inhabitants and research design. The broadly reported STEP 1 trial, the outcomes of which have been revealed within the New England Journal of Drugs, demonstrated a median of 14.9% physique weight discount after 68 weeks of remedy in these assigned to the medicine group, versus solely 2.4% weight reduction in these assigned to the placebo group. The typical weight reduction seen with present anti-obesity drugs is usually about 5% to 9%, whereas these engaged in way of life and behavioral remedy alone are anticipated to lose solely 3% to five% of their physique weight.
The commonest unintended effects of Wegovy are nausea, diarrhea, vomiting, and constipation. The medicine additionally comes with a warning for danger of a particular tumor of the thyroid, and thus it isn’t advisable for these with a private or household historical past of medullary thyroid most cancers or a number of endocrine neoplasia sort 2 (a genetic situation related to endocrine tumors). It needs to be famous that tumors have been solely noticed in animal research, and never seen within the human trials.
How lengthy can you are taking Wegovy?
Wegovy is one in every of six drugs at the moment authorized by the FDA for the long-term remedy of weight problems. As such, it may be used for so long as it stays useful for weight reduction and/or weight upkeep and isn’t inflicting insupportable unintended effects. The primary GLP-1 RA medicine to realize FDA approval was exenatide in 2005; since then, a number of GLP-1 RAs have been authorized and undergone long-term trials demonstrating both non-inferiority or superiority, when in comparison with placebo for main hostile cardiovascular occasions corresponding to coronary heart assaults and stroke. The SELECT trial is the long-term cardiovascular outcomes trial for Wegovy that goals to evaluate its results on coronary heart illness and stroke in sufferers with chubby and weight problems; it’s at the moment ongoing and anticipated to be accomplished in September 2023.
Anti-obesity medicine administration: An evolving panorama
Wegovy is the newest in a line of medicines, beginning with phentermine in 1959, which have achieved FDA approval for the remedy of weight problems. At the moment there are 10 FDA-approved anti-obesity drugs within the US: phentermine, diethylpropion, benzphetamine, phendimetrazine, orlistat, phentermine/topiramate ER (Qsymia), bupropion/naltrexone (Contrave), liraglutide (Saxenda), setmelanotide (Imcivree), and now semaglutide (Wegovy). Of word, setmelanotide is simply authorized for the remedy of weight problems attributable to particular, uncommon genetic circumstances. Different drugs corresponding to metformin, zonisamide, and different GLP-1 RAs usually used for treating diabetes are sometimes prescribed “off label” and on the discretion of the prescriber for the remedy of weight problems.
Treatment remedy of weight problems has been a tumultuous area tormented by many situations of therapeutics being unable to exhibit ample security information to warrant FDA approval, corresponding to rimonabant (Acomplia); or of hostile results necessitating market withdrawal, corresponding to lorcaserin (Belviq), sibutramine (Meridia), dexfenfluramine (Redux), fenfluramine (Pondimin), and the notorious mixture medicine fen-phen — a drug which, regardless of its excessive recognition within the Nineties, was by no means truly granted FDA approval. Sadly, the rocky anti-obesity medicine panorama typically results in discomfort amongst clinicians in utilizing the various protected and efficient instruments we at the moment have for treating weight problems, or worse, hesitance to handle weight problems as a well being concern in any respect.
Paying for anti-obesity drugs
For individuals who do prescribe anti-obesity pharmacotherapy, challenges come up with the exorbitant value of a few of the newer therapeutics, in addition to refusal of many personal and public insurers to cowl anti-obesity drugs. Typically sufferers or their advocates could have success in lobbying their employers to choose in to insurance coverage protection for weight problems administration. Nevertheless, for these on Medicare or Medicaid, there’s at the moment completely no protection for anti-obesity drugs. Sufferers with out protection are left with the selection of paying out of pocket for a lower-cost generic anti-obesity medicine; taking a medicine primarily supposed for treating different medical circumstances corresponding to diabetes or seizures which will additionally assist with weight reduction; or, if their BMI and well being standing is extreme sufficient to fulfill insurance coverage necessities, they might go for bariatric surgical procedure, a way more broadly lined insurance coverage profit.
The Deal with and Cut back Weight problems Act is a invoice that was first launched to Congress in 2012 and most just lately reintroduced in 2021, with the aim of amending the Medicare Social Safety Act to authorize insurance coverage protection of weight problems counseling companies and FDA-approved anti-obesity drugs. This stays the most important hurdle within the weight problems remedy panorama: gaining ample buy-in from authorities businesses, employers, and insurers by convincing them that drugs concentrating on essentially the most prevalent continual illness within the US are literally price paying for.