Will the FDA or EMA withdraw approval of semaglutide for the treatment of obesity or diabetes in 2024?
Resolved:NoMake a Prediction
Did this actually happen?No
Will the FDA or EMA withdraw approval of Semaglutide for the treatment of obesity by 2027?
Will oral semaglutide be approved for the treatment of obesity by the FDA or EMA by 2027?
Will the combination of semaglutide and cagrilintide be approved for the treatment of obesity by the FDA or EMA by 2027?
Comments
If this happened, it was handled very quietly. My research finds nothing. Should resolve January 23rd.
I'm reaffirming my view but also commenting to ask:
Does anyone know if the eminent scientist, physician, public-health veteran, and nutritionist Robert F. Kennedy has drawn a conclusion about the drug following his usual rigorous laboratory study?
My prediction could change.
It seems that most adverse event reports FDA receives are related to compounded semaglutide. Some compounders are allowed but regulators don't review compounded versions of these drugs for safety, effectiveness, or quality.
Does anyone know what the base rate is for the FDA withdrawing approval of drugs in general? I think it's fairly low, but haven't looked at actual data.
@Dumbledores_Army I made a very sloppy search and got something like 2 withdrawals per year against 30 approvals per year. I have no idea if those numbers make sense -- 30 approvals in particular sounds kinda low to me.
@Dumbledores_Army this is the closest I found after a quick search when I was looking earlier, it doesn't match up well with the novel drugs approved per year numbers though. Might be treating compounds/generics/etc differently?
WSJ: Weight-Loss Drugs Don’t Cause Suicidal Thoughts, FDA Says
The Food and Drug Administration’s preliminary analysis Thursday showed no clear relationship between adverse-event reports of suicidal thoughts or actions and the drugs for weight-loss and diabetes, glucagon-like peptide-1 receptor agonists, or GLP-1s. Millions of people have started taking drugs that can help some users shed a fifth of their body weight or more.
It would seem that the current evidence indicates some serious adverse effects that would merit a boxed warning. I think semaglutide already has a boxed warning.
Also, semaglutide as too many other positive effects, such as better cardiovasular outcomes, so it may be seen as a net benefit, even considering suicide ideation, gastroparesis, or a slightly elevated cancer risk.
As the introduction states, large clinic trials of tens of thousands of individuals did not detect an increase in cancer. I think something major would come up.
IIRC, drugs that are withdrawn now usually have accelerated approval where further analysis indicates that the drugs are not that effect. While browsing Wikipedia, this drug came to mind:
Umbralisib (Ukoniq) was granted accelerated approval for medical use in the United States in February 2021.[2][6][7] However, due to concerns for increased long term side effects leading to inferior overall survival which led to increased FDA scrutiny in the form of an ODAC review,[8] it has been withdrawn from the US market.[9]
Updated findings from the UNITY-CLL clinical trial show a possible increased risk of death in people receiving Ukoniq.[3] As a result, the FDA determined the risks of treatment with Ukoniq outweigh its benefits.[3] Based upon this determination, the drug's manufacturer, TG Therapeutics, announced it was voluntarily withdrawing Ukoniq from the market for the approved uses in MZL and FL.[3][10]
https://en.wikipedia.org/wiki/Umbralisib
I don't think semaglutide had accelerated approval or was "fast-tracked", so regulators made judgments on more thorough data, where an adverse side effect would show up. I think that reduces the potential for a type II error, that there is a significant negative effect, but instead the null hypothesis is favored where the adverse effect occurs at a similar frequency to placebo.
Axios: FDA probing possible weight-loss drug side effects, including suicidal thoughts
The Food and Drug Administration is examining reports of suicidal thoughts and other possible side effects linked to a class of blockbuster obesity drugs and whether it needs to take regulatory action.
Driving the news: An update to the agency's adverse event reporting system cited the risk of suicidal ideation; alopecia, or hair loss; and inhalation of stomach contents is connected to drugs treating diabetes and weight loss that include Wegovy, Ozempic, Mounjaro and Zepbound.
johnnycaffeine
·This question resolves as No. Neither the FDA nor the EMA are reported to have withdrawn approval of semaglutide.