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New Weight Loss Medication Wegovy™ Approved by the FDA

Posted: Jun 04 in Weight Loss Medication by

Today the FDA approved semaglutide 2.4 mg weekly injection for chronic weight management. The brand name will be Wegovy™.*

The molecule semaglutide has been used for the treatment of type II diabetes for the past 5 years at doses of up to 1 mg. Novo Nordisk is also seeking an approval for a 2 mg weekly dose for diabetes. However, Wegovy™, the 2.4 mg dose, is approved for chronic weight management whether or not the person has diabetes.

Wegovy™

Wegovy™ is the 5th new weight loss medication approved by the FDA since 2012. The mechanism of action is similar to Saxenda™. It is known as a GLP-1 analogue (glucagon like peptide-1). GLP-1 is a hormone your small intestine normally makes in response to food intake. It signals your brain and your stomach that you are done eating, providing control of appetite, satiety, and a decrease in stomach peristalsis (pumping). The existing Ozempic™ has been a great drug to have in our armamentarium against diabetes, because it is extremely effective and safe. In fact, in addition to lowering the blood sugars, it lowers the risk of heart attack and stroke.

Now referred to as anti-obesity medications, Wegovy™ also offers very convenient dosing. It is a self-administered injection, and is only injected once per week. The injections are simple and don’t hurt. Imagine doing an injection once a week during the weekend and then not having to take any pills all week!

Wegovy™ vs Saxenda™

We have had great experience with Saxenda™ over the past 7 years, but Saxenda™ requires an injection every day. Further, compared to the Saxenda™, the Wegovy™ offers more than 50% greater weight loss on average, with the typical patient losing 15% of their body weight (34 pounds). Many even lose 20% – or more! This is significantly more potent than all of the currently available weight loss medications. Novo Nordisk is also developing a pill version of this medication.

It is important to understand that similar to diabetes and blood pressure medications, anti-obesity medications only work if taken chronically. If the medication is stopped, study participants typically regained the lost weight.

Pricing Information

The new weight loss medication Wegovy™ should be available at retail pharmacies on or around June 17th, 2021. So why weight? Now is a great time to call your health insurance company and see if they will cover Wegovy™. Although the price has not been announced, we expect the price to be around $25 / month for those with insurance coverage (similar to Saxenda), or for those without, over $1,000 / month.

*Wegovy™, a glucagon-like peptide-1 (GLP-1) receptor agonist, is indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adults with obesity (BMI ≥30 kg/m2), or overweight (BMI≥27 kg/m2) with at least one weight related comorbidity.  Please read the full announcement here

More information here.

Read more about Wegovy in the news – Dr. Lazarus was interviewed in these articles:

USA Today

Bloomberg

Wegovy™ Indication and Important Safety Information

What is Wegovy™?

Wegovy™ (semaglutide) injection 2.4 mg is an injectable prescription medicine used for adults with obesity (BMI ≥30) or overweight (excess weight) (BMI ≥27) who also have weight-related medical problems to help them lose weight and keep the weight off.

  • Wegovy™ should be used with a reduced calorie meal plan and increased physical activity.
  • Wegovy™ contains semaglutide and should not be used with other semaglutide-containing products or other GLP-1 receptor agonist medicines.
  • It is not known if Wegovy™ is safe and effective when taken with other prescription, over-the- counter, or herbal weight loss products.
  • It is not known if Wegovy™ can be used safely in people with a history of pancreatitis.
  • It is not known if Wegovy™ is safe and effective for use in children under 18 years of age.

Important Safety Information

What is the most important information I should know about Wegovy™? Wegovy™ may cause serious side effects, including:

  • Possible thyroid tumors, including cancer. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rodents, Wegovy™ and medicines that work like Wegovy™ caused thyroid tumors, including thyroid cancer. It is not known if Wegovy™ will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.
  • Do not use Wegovy™ if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

Do not use Wegovy™ if:

  • you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
  • you have had a serious allergic reaction to semaglutide or any of the ingredients in Wegovy.

Before using Wegovy™, tell your healthcare provider if you have any other medical conditions, including if you:

  • have or have had problems with your pancreas or kidneys.
  • have type 2 diabetes and a history of diabetic retinopathy.
  • have or have had depression, suicidal thoughts, or mental health issues.
  • are pregnant or plan to become pregnant. Wegovy™ may harm your unborn baby. You should stop using Wegovy™ 2 months before you plan to become pregnant.
  • are breastfeeding or plan to breastfeed. It is not known if Wegovy™ passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Wegovy™ may affect the way some medicines work and some medicines may affect the way Wegovy™ works. Tell your healthcare provider if you are taking other medicines to treat diabetes, including sulfonylureas or insulin. Wegovy™ slows stomach emptying and can affect medicines that need to pass through the stomach quickly.

What are the possible side effects of Wegovy™?
Wegovy™ may cause serious side effects, including:

  • inflammation of your pancreas (pancreatitis). Stop using Wegovy™ and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.
  • gallbladder problems. Wegovy™ may cause gallbladder problems, including gallstones. Some gallstones may need surgery. Call your healthcare provider if you have symptoms, such as pain in your upper stomach (abdomen), fever, yellowing of the skin or eyes (jaundice), or clay- colored stools.
  • increased risk of low blood sugar (hypoglycemia) in patients with type 2 diabetes, especially those who also take medicines for type 2 diabetes such as sulfonylureas or insulin. This can be both a serious and common side effect. Talk to your healthcare provider about how to recognize and treat low blood sugar and check your blood sugar before you start and while you take Wegovy. Signs and symptoms of low blood sugar may include dizziness or light-headedness, blurred vision, anxiety, irritability or mood changes, sweating, slurred speech, hunger, confusion or drowsiness, shakiness, weakness, headache, fast heartbeat, or feeling jittery.
  • kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems to get worse. It is important for you to drink fluids to help reduce your chance of dehydration.
  • serious allergic reactions. Stop using Wegovy™ and get medical help right away, if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue, or throat; problems breathing or swallowing; severe rash or itching; fainting or feeling dizzy; or very rapid heartbeat.
  • change in vision in patients with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Wegovy.
  • increased heart rate. Wegovy™ can increase your heart rate while you are at rest. Tell your healthcare provider if you feel your heart racing or pounding in your chest and it lasts for several minutes.
  • depression or thoughts of suicide. You should pay attention to any mental changes, especially sudden changes in your mood, behaviors, thoughts, or feelings. Call your healthcare provider right away if you have any mental changes that are new, worse or worry you.
  • the most common side effects of Wegovy™ may include: nausea, diarrhea, vomiting, constipation, stomach (abdomen) pain, headache, tiredness (fatigue), upset stomach, dizziness, feeling bloated, belching, gas, stomach flu and heartburn.

Please see Prescribing Information including Medication Guide 1, 10

Comments

6 Responses to “New Weight Loss Medication Wegovy™ Approved by the FDA”
  • Marianne delucio says:

    My insurance is kaiser and I am sure they will not cover cost. Is there another program for weight loss that is not so expensive. I was so excited but when I saw $1000 a month disappointed.

  • Paulette Perry says:

    How can I get a prescription for Wegovy

    • Dr. Lazarus says:

      Hi Paulette – Novo Nordisk tells me that Wegovy will be available for me to prescribe for weight loss / chronic weight management sometime after June 17th. I am also supposed to receive samples sometime between then and the 23rd. Why not see if you have insurance coverage, than schedule a visit with me (or your doctor) once you confirm your pharmacy has it in stock.

  • MELISSA D OCEAN says:

    I would like to schedule a weight management appointment and try Wegovy. My insurance carrier is BCBSNC.

    • Dr. Lazarus says:

      Melissa – feel free to call the office at 303-750-9454 and set up a consultation. However, Wegovy is not available yet – Novo is telling me it should be shipping on or after June 17th. If you’d specifically like to start Wegovy, please contact your insurance provider and see if you have coverage for Wegovy. If not listed yet, ask if you have coverage for Saxenda – if you have coverage for Saxenda, you should have coverage for Wegovy. Also, contact your pharmacy – make sure they have it in stock. I expect to be able to start prescribing Wegovy for weight loss as soon as next week. Thanks for your interest!

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