Merck Asks FDA For Emergency Approval Of New COVID Drug Despite Safety Concerns

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Merck Asks FDA For Emergency Approval Of New COVID Drug Despite Safety Concerns

ZH [Emphasis mine.]| OCT 11, 2021

Despite warnings from scientists that its new COVID drug could have seriously harmful side effects like causing cancers and birth defects, Merck officially submitted the drug, Molnupiravir, to the FDA for approval. If it's approved, it would be the first antiviral pill to treat the virus.

According to the NYT, the drug would revolutionize COVID treatment since it would be able to relatively inexpensively treat many more high-risk patients sick with COVID, especially those that haven't been vaccinated (the drug was only tested on patients who hadn't been vaccinated). Still, the drug will be a cash cow for Merck, since Merck is planning to charge customers 40x the cost to make the drug.

Despite the price, countries are lining up for deals with Merck even before the drug has been approved. Merck has struck deals with the US government, as well as South Korea, Singapore, Malaysia, Australia and others.

The $700 course of the pill is meant to be taken at home as four capsules twice a day for five days, constituting a total of 40 pills. Per the trial data released by Merck - which was greeted with fawning from doctors and scientists - it halved hospitalizations and deaths (though the trial was cut short by a supervisory board who claimed the data was so positive it would be unethical to withhold the drug from the placebo group). The approval could come within weeks, per the NYT.

As many as 10MM Americans would be eligible for the drug if approved, but the supply will likely be slim initially; the US has ordered 1.7MM courses already.

Fortunately, other companies are nearly ready to release data from their own antiviral pill trials. An antiviral pill being developed by Pfizer and one from Atea Pharmaceuticals teamed up with Roche will report study results in the next months.

The FDA has many decisions to make beyond just approving the drug, or not. It must decide whether pregnant women - and any other at-risk groups - will be eligible. Initially, Merck is seeking authorization for its pill to be given only to high-risk adults, including people with any of the following characteristics: over 60, have obesity, diabetes or heart disease.