Company Pushes for FDA to Approve Covid Treatment Pill

Merck & Co. Inc has asked the FDA to approve their Covid pill for emergency use authorization. The new drug, molnupiravir, can treat mild to moderate covid symptoms in patients at a higher risk of hospitalization. If the pill is cleared, it would be the first Covid drug that could be taken without the need for IV or injection.

The pill could be taken orally, at home, without a hospital stay.

In trials, molnupiravir cut hospitalization rates and deaths by 50% in mild-to-moderately ill people. Dr. Nicholas Kartsonis, a senior vice president with Merck’s infectious disease unit, said, “The value here is that it’s a pill, so you don’t have to deal with the infusion centers and all the factors around that. I think it’s a very powerful tool to add to the toolbox.”

The ability to treat Covid with an antiviral pill will help lessen the load on U.S hospitals and help outbreaks in poorer countries that have weaker healthcare systems.

According to the Associated Press, “It would also bolster the two-pronged approach to the pandemic: treatment, by way of medication, and prevention, primarily through vaccinations.”

Merck reported that the side effects between the dummy pill group and those who got the drug were similar. They did not disclose the types of problems that were reported. The FDA will review any issues before deciding to move forward with authorization. If the FDA moves ahead with approval, the pill could be rolled out within a matter of weeks.

Merck isn’t the only pharmaceutical company attempting to produce a Covid pill.

Pfizer and Roche are “also studying similar drugs and are expected to report results in the coming weeks and months.” AstraZeneca also seeks FDA approval for their long-acting antibody drug for people with immune disorders who don’t respond well to the vaccine. The antibody drug is intended to provide these patients months of protection.

According to the New York Times, “A five-day course of molnupiravir will cost about $700 per patient — a third of the amount of a monoclonal antibody treatment.”

Merk anticipates making about 10 million treatments, which is equivalent to 400 million capsules, by the end of 2021. Paul Schaper, Merck’s executive director of global pharmaceutical policy, said, “Substantially more will be produced in 2022.” In June, Merck agreed to a $1.2 billion supply deal with the U.S. to make 1.7 million treatment doses.

Even with the development of Covid treatments, Dr. Anthony Facui continues to push vaccinations as the sole solution. He said, “It’s much, much better to prevent yourself from getting infected than to have to treat an infection.”

 

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