An FDA panel to discuss Merck’s COVID-19 pill on Tuesday; here is what you need to know

A Food and Drug Administration advisory group will meet on Tuesday to discuss a possible emergency authorization for the use of Merck’s antiviral drug to treat COVID-19.

The pill, developed in partnership with Ridgeback Biotherapeutics, aims to reduce serious illness and mortality in COVID-19 patients. Merck asked the FDA in October to approve the drug, named molnupiravir, for adults with mild to moderate COVID-19 infections who are at risk of hospitalization.

What did Merck’s updated research on the pill show?

On Friday, Merck released updated data, based on 1,433 unvaccinated patients, which showed its drug reduced hospitalizations and deaths by 30%. This is a significant decrease from preliminary data released last month, showing a 50% reduction based on 775 unvaccinated patients. Merck’s full data has not yet been published or peer reviewed.

The new findings have dampened some of the enthusiasm surrounding the oral treatment, which, if approved for emergency use, would be the first such antiviral pill used to treat COVID-19.

In its analysis of the pill, the FDA said scientists had identified some potential risks, including possible toxicity to developing fetuses and birth defects. The FDA will ask the advisory committee if the drug should ever be administered during pregnancy, the Associated Press reported.

The drug will not be used in children, the FDA said.

What do we know about another COVID-19 pill developed by Pfizer?

Rival pharmaceutical company Pfizer is also working on an antiviral pill, called paxlovid, to treat the virus. Initial results from the study of around 1,200 patients showed the drug reduced hospitalizations and deaths by 89%.

Pfizer has submitted paxlovid for FDA review, although it is not clear when the agency will review the drug. Like Merck, Pfizer has yet to release full data or subject it to peer review.

How would the COVID-19 pill help hospitals?

Oral antiviral treatment for COVID would provide an additional tool for healthcare providers trying to reduce the strain the virus places on hospitals.

“Right now, all of our proven effective therapies are drugs or IV treatments that we give to hospitalized people, or monoclonal antibodies, which have been shown to be very effective and effective in treating outpatients, but require an infusion. IV, ”said Dr. James Cutrell, associate professor of medicine in the Department of Infectious Diseases and Geographic Medicine at the University of Texas Southwestern Medical Center.

How do Merck and Pfizer COVID-19 pills work?

During clinical trials, patients receiving Merck treatment took a total of 40 tablets over the five days. Patients receiving Pfizer treatment took a total of 30 tablets over five days. Treatments should be started within five days of symptom onset.

Both drugs prevent the COVID-19 virus from replicating, but they do so at different points in the replication process.

Merck’s pill interferes with the way the virus copies its genetic material, causing mutations. “Eventually there are so many mistakes or mutations created that the virus somehow dies,” Cutrell said.

Pfizer’s treatment operates in a different part of the viral life cycle, instead interfering with an enzyme needed for replication. Treatment consists of two components, an experimental molecule and a medicine called ritonavir, which has been used in HIV patients before.

The molecule interacts with the virus while ritonavir prevents other enzymes from destroying it, Becker’s Hospital Review reported.

What are the limits of COVID-19 pills?

The new drugs, while potentially useful in preventing serious illnesses caused by COVID-19, have limitations, said Catherine Troisi, associate professor of epidemiology at the University of Texas Health Sciences Center at Houston.

Many times people infected with COVID-19 don’t know they have the virus until several days after symptoms start, meaning antiviral pills are unlikely to be effective by the time these people are treated.

Access to pills is also a concern. “If you have your primary care doctor and you can get it right away, then that’s great,” Troisi said. “But a lot of people don’t have that.”

If either pill is cleared for emergency use, there will still be questions about cost and availability, Cutrell said.

“These are all important issues that we will watch out for when the FDA panel looks at the data and then once we see what decision is made,” he said.

The Associated Press contributed to this report.

Left to right: Nurses Kelsey O'Meara, Noelle Hackfeld and Joanna Pless examined the oxygen levels of an intubated COVID-19 patient at the Tactical Care Unit at Parkland Hospital on February 10, 2021 in Dallas .
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