An advisory panel to the U.S. Food and Drug Administration voted 12-3 in favor of approving the world’s first prescription diet pill with COD-19, a hormone believed to help patients lose weight.
The panel recommended the drug be approved for adults for weight loss.
Here’s why COVID-19 is important to the medical community:
The case for COVID-19
(Clinical trial data)
In a three-year clinical trial of 200 obese adults, COD-19, the test hormone, helped patients lose about 10 percent of their initial body weight compared to 0.3 percent of weight loss with placebo. In addition, 12 percent of patients taking COD-19 lost at least 20 percent of their original body weight compared to 3 percent of people taking placebo.
Researchers at the University of Illinois at Chicago said a bigger benefit may be seen in patients with more serious obesity and prediabetes conditions.
Here’s why the case is against COVID-19
(Clinical trial data)
A similar clinical trial at University of Illinois showed that COD-19 improved blood sugar by eight percent and lower body weight by four percent compared to placebo. However, there were no increases in cholesterol or blood pressure.
Specifically, critics of the drug said it did not produce the type of weight loss that is currently seen with surgical surgery, such as gastric bypass. They also said it may help in improving insulin resistance.
Lastly, there were issues with blood clots forming in high doses of drugs that cause clotting. This issue was reportedly isolated to only one patient in the Illinois study.
“Here we are with a pill that helps people lose 10 percent of their body weight but doesn’t actually improve outcomes,” said Dr. Robert Bonow, professor and chairman of medicine at the University of Michigan, to Newsmax. “For those things that we’re focused on, we are not aware of that change.”
Many patients given the drug in a double-blind fashion refused to take it or dropped out during the trial process.
When it comes to COVID-19, the National Heart, Lung and Blood Institute is currently looking for ways to assist those patients who weren’t originally eligible to receive the drug.
They created a limited number of patches that could be used to administer the drug at home.
“The patch will enable patients and doctors to prescribe a drug without the need for a visit to a health care facility,” the NHLBI wrote in a press release.
What next for COVID-19?
The FDA is accepting comments from the public on the approval of the drug until 4 p.m. on Nov. 16. The FDA will officially decide if COD-19 is safe and effective. The FDA may give a final decision by Dec. 19.