Wegovy [Semaglutide] new weight loss drug approved by FDA

Darshan Singh
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 Wegovy new weight loss drug approved by FDA

U.S. Food and Drug Administration approved the most awaited obesity drug Wegovy which contains Semaglutide 2.4 mg in injection form. As per U.S. FDA, the medicine is advised once a week for chronic weight loss management. In patients with high B.P., Diabetes type 2, and high cholesterol, this drug is recommended with physical activity. Wegovy new weight loss drug approved by FDA is increased strength of 2.4 mg to Ozempic drug. 

On 23 December 2022, The US FDA approved the weight loss medicine Wegovy (Semaglutide) for use in teens ages 12 and up, they must have a BMI at or above the 95th percent for their age and sex. Semaglutide is now the first once-weekly weight loss drug approved for adolescents

It is the first medication for weight loss since 2014 and is available in under-the-skin injection.

Wegovy [Semaglutide] new weight loss drug approved by FDA


Wegovy new weight loss drug
The U.S. FDA has granted approval to a US-based Novo Nordisk pharma company. Semaglutide 1 mg injection (Ozempic) was first approved as a treatment for type 2 diabetes in 2017. Approval Letter.

How Wegovy (Semaglutide) works to reduce weight?

Wegovy copies the hormone that is known as glucagon-like peptide-1 (GLP-1) which affects the areas of the brain that regulate appetite and food intake. The dose of this drug is increased gradually over the period of 16 to 20 weeks to 2.4 mg weekly that reducing the gastrointestinal side effects.

The use of Wegovy is not advised with other GLP-1 receptor agonists which are intended for weight loss, OTC products, herbal products, or any prescribed medicine.


Wegovy's (Semaglutide) safety and efficacy:


According to FDA:- "Wegovy’s safety and efficacy were studied in four 68-week trials. Three were randomized, double-blind, placebo-controlled trials (including 16 weeks of dose increases) and one was a double-blind, placebo-controlled, randomized withdrawal trial in which patients receiving Wegovy either continued with the treatment or switched to a placebo. More than 2,600 patients received Wegovy for up to 68 weeks in these four studies and more than 1,500 patients received placebo.

The U.S. FDA suggests that the largest placebo-controlled trial enrolled adults without diabetes. The average age at the start of the trial was 46 years and 74% of patients were female. The average body weight was 231 pounds (105 kg) and the average BMI was 38 kg/m2. Individuals who received Wegovy lost an average of 12.4% of their initial body weight compared to individuals who received a placebo. Another trial enrolled adults with type 2 diabetes. The average age was 55 years and 51% were female. The average body weight was 220 pounds (100 kg) and the average BMI was 36 kg/m2. In this trial, individuals who received Wegovy lost 6.2% of their initial body weight compared to those who received a placebo." 

Dosage of Wegovy [Segmaglutide]

Wegovy is advised to be administered a once-weekly subcutaneous injection. The dose of Semaglutide can be increased gradually over 16 to 20 weeks to 2.4 mg once weekly to reduce gastrointestinal side effects. The maintenance dose of Wegovy is 2.4 mg once weekly.: APNews



Common side effects of Wegovy?

  • Wegovy may have the following side effects:
  • Nausea, diarrhea, vomiting,
  • Constipation, abdominal (stomach) pain.
  • Headache, fatigue,
  • Dyspepsia (indigestion),
  • Dizziness, abdominal distension,
  • Eructation (belching),
  • Hypoglycemia (low blood sugar) in patients with type 2 diabetes (Serious)
  • Flatulence and gastroenteritis
  • Gastroesophageal reflux disease (a type of digestive disorder)

Since the Wegovy contains a boxed warning for the potential risk of thyroid C-cell tumors. Therefore, Wegovy should not be used in patients with a personal or family history of medullary thyroid carcinoma or in patients with a rare condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

warning for thyroid-c cell tumor

Semgaglutide Contradictions

• Personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2 (4, 5.1).
 • Known hypersensitivity to semaglutide or any of the excipients in WEGOVY (4).

New weight loss drug approved by FDA

Wegovy is indicated for adults who are obese (body mass index ≥30) or overweight (body mass index ≥27), and who also have certain weight-related medical conditions, such as type 2 diabetes, hypertension, and high cholesterol.

What is the difference between Wegovy and Ozempic?

Ozempic is a Semaglutide 0.5 mg and 1 mg injection form medicine that is used for the treatment of overweight or obesity. The medication is effective in weight loss prescriptions. 

 Otherside, Wegovy is a higher-dose - 2.4 mg (semaglutide). - version of the diabetes drug Ozempic. It is approved on 4th June 2021 by U.S. FDA.  

 How does Semaglutide help lose weight?

Usually, the semaglutide ( or Ozempic) course starts with a dose of 0.25 mg injected under your skin once a week for 4 weeks (1 month).  After 4 weeks you can use a higher dose of semaglutide up to 2.4 mg once a week.  The standard dosing schedule might look like this: Month 1: 0.25 mg once a week

How much weight can you lose on Ozempic?

The answer to this question can not be given in specific numbers, it totally depends on your body type, the activity you do along with the semaglutide course, usually in model conditions you may lose 9 to 12 lbs in three months. 

How long do you take Wegovy?

The use of Wegovy totally depends on the physician's prescription, and how long the physician feels is optimum for you. Usually, The dose of this drug is increased gradually over the period of 16 to 20 weeks to 2.4 mg weekly reducing the gastrointestinal side effects.

Is Ozempic better than Trulicity?

Trulicity is a dulaglutide injection available in 0.75 mg, 1.5 mg, 3 mg, and 4.5 mg doses. Trulicity is used to lower the sugar level in type 2 diabetes and also controls the A1C.  Moreover, it lowers the risk of cardiovascular events like heart attack, stroke, or death in people with type 2 diabetes with known heart disease or multiple risk factors.

Otherside, Ozempic is a Semaglutide 0.5 mg and 1 mg injection form medicine that is used for the treatment of overweight or obesity. The medication is effective in weight loss prescriptions.

Wegovy Vs Trulicity?

Wegovy and Trulicity both drugs are different fundamentally because both medicines contain different molecules that are different in category and class of drugs. 

Wegovy contains Semaglutide 2.4 mg, used for weight loss primarily, however, the drug is found efficient in diabetes management also. 

Otherside, Trulicity is a medicine that contains dulaglutide in the form of injectable pens that are administered under the skin subcutaneously. It is used to treat type 2 diabetes mellitus. Trulicity is also very helpful in diabetes patients who are at risk of heart strokes. It minimizes the risk of sudden heart failure and related problems.

What is the best weight loss injection?

There are lots of drugs approved by the FDA for the treatment of obesity and weight loss in type 2 diabetic patients. Including Ozempic and Wegovy 2.4 mg injection for weight loss, however, the use of these drugs is strictly advised under the guidance of a physician or other healthcare professional. 

References:

  1. USFDA reference Id-4806455
  2. MedlinePlus[https://medlineplus.gov/druginfo/meds/a618008.html]
  3. Once-Weekly Semaglutide in Adults with Overweight or Obesity[https://www.nejm.org/doi/full/10.1056/NEJMoa2032183]
  4. Webmd.com[https://www.webmd.com/drugs/2/drug-174490/semaglutide-subcutaneous/details]

Disclaimer:

The information provided in this article is for informational purposes only and should not substitute professional medical advice. Do not start this medication without the recommendations of a Health Professional.




   

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