Merck seeks FDA emergency use authorization for antiviral COVID-19 treatment molnupiravir

Merck antiviral
Posted at 3:30 PM, Oct 11, 2021
and last updated 2021-10-11 17:32:00-04

(WXYZ) — Pharmaceutical giant Merck has applied for Emergency Use Authorization for its promising antiviral COVID-19 treatment. If the FDA grants approval, it would be the first pill in the US to treat the coronavirus disease.

It’s definitely encouraging. When it comes to treating COVID, Merck’s oral antiviral treatment called Molnupiravir could very well be groundbreaking. This pill, according to research, has the potential to reduce hospitalizations or death by nearly 50% in patients who have early symptoms. So not only could it potentially help people who get infected, but it could help my fatigued colleagues at hospitals that are overwhelmed with sick COVID patients. Not to mention it could help with outbreaks in poorer countries that are still struggling to get COVID vaccines. Or those with weak health care systems. But before any of that happens, the FDA needs to closely scrutinize the data from Merck’s clinical trials. And make sure that the antiviral treatment is not only effective but also safe. Now, there were over 700 participants and the final trial was cut short because the antiviral treatment was working so well. But we have not yet heard what the side effects were as Merck did report that participants in both the placebo group and the group taking the experimental pill experienced adverse effects.

Now there are other antibody drugs that can be given after COVID-19 exposure. But Merck’s oral antiviral treatment is much simpler.

There are three FDA-authorized antibody drugs. But the main ones we use here in the US are from Regeneron and Eli Lilly & Co. However, all of the approved antibody treatments require an IV or an injection. So they need to be administered in a medical setting. Whereas molnupiravir is a capsule that potentially can be taken at home. Plus, it’s much cheaper than the other treatments. So it has a lot of positives going for it. But we’ll know more details once the FDA has combed through Merck’s data. And I expect we’ll have a yes or no regarding emergency use authorization in a few weeks.

Now, I want to stress again, that antibody treatments are not a replacement for vaccines. Merck’s antiviral pill, if approved, will be another tool in the toolbox to help speed recovery. But the best protection, in my opinion, is to get vaccinated against COVID-19.