June 6, 2021

FDA Approves First New Weight Loss Drug Since 2014, Issues EUA for COVID-19 Antibody

FDA Approves Wegovy for Weight Loss

The FDA approved Wegovy (semaglutide) weekly injections for chronic weight management in adults with obesity or overweight with at least one weight-related condition – such as high blood pressure, type 2 diabetes, or high cholesterol – for use in addition to a reduced calorie diet and increased physical activity.

In the FDA’s announcement, they state that losing 5-10% of body weight through diet and exercise has been associated with a reduced risk of cardiovascular disease in patients with obesity or overweight. Because this drug can assist with weight loss, it has the potential to reduce the impact that comorbid conditions have on a workers’ comp claim, helping to better facilitate recovery in injured worker patients.

However, considering the number of common side effects and special warnings with this drug, if a patient receives Wegovy, their drug regimen should be carefully monitored to avoid drug-drug or drug-disease interactions.

The approved drug label features several warning and precautions, including those tied to:

  • Thyroid C-cell tumors
  • Acute pancreatitis
  • Acute gallbladder disease
  • Hypoglycemia
  • Acute kidney injury
  • Hypersensitivity
  • Diabetic retinopathy complications in patients with type 2 diabetes
  • Heart rate increase
  • Suicidal behavior and ideation

Common side effects of Wegovy include 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, flatulence (gas buildup), gastroenteritis (an intestinal infection) and gastroesophageal reflux disease (a type of digestive disorder).

Wegovy should not be used in combination with other semaglutide-containing products, other GLP-1 receptor agonists, or other products intended for weight loss, including prescription drugs, over-the-counter drugs, or herbal products. Wegovy has not been studied in patients with a history of pancreatitis.

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).

FDA Issues EUA for Sotrovimab for COVID-19

The FDA issued a new emergency use authorization (EUA) for the use of sotrovimab – an investigational monoclonal antibody – for the treatment of mild-to-moderate COVID-19 in adults weighing at least 40 kilograms (about 88 pounds) who are at high risk of progression to severe COVID-19.

Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful antigens such as viruses. Sotrovimab is a monoclonal antibody that is specifically directed against the spike protein of SARS-CoV-2 and is designed to block the virus’ attachment and entry into human cells.

Sotrovimab is not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19. This treatment has not shown benefit in patients hospitalized due to COVID-19 and monoclonal antibodies may be associated with worse clinical outcomes when administered to hospitalized patients requiring high flow oxygen or mechanical ventilation.

An EUA is not the same as an FDA approval. With an EUA, the FDA evaluates available evidence and carefully balances any known or potential risks with known or potential benefits for use during an emergency.

Data supporting this EUA for sotrovimab are based on an interim analysis from a phase 1/2/3 randomized, double-blind, placebo-controlled clinical trial in 583 non-hospitalized adults with mild-to-moderate COVID-19 symptoms.

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