FDA panel to discuss Merck’s COVID-19 pill on Tuesday; this is what you need to know – Community News

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

A Food and Drug Administration advisory panel will meet Tuesday to discuss the potential emergency use authorization for Merck’s antiviral drug to treat COVID-19.

The pill, developed in collaboration with Ridgeback Biotherapeutics, aims to reduce severe illness and death in COVID-19 patients. Merck asked the FDA in October to approve the drug, called 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 find?

On Friday, Merck released updated data, based on 1,433 unvaccinated patients, showing the drug reduced hospitalizations and deaths by 30%. That’s a significant drop 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 results dampened some of the excitement 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 have identified some potential risks, including potential toxicity to developing fetuses and birth defects. The FDA will ask the advisory panel whether the drug should ever be given 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 being developed by Pfizer?

Competing pharmaceutical company Pfizer is also working on an antiviral pill called paxlovid to treat the virus. The first study results of about 1,200 patients showed that the drug reduced hospitalizations and deaths by 89%.

Pfizer has submitted paxlovid for FDA review, although it’s unclear when the agency will evaluate the drug. Like Merck, Pfizer has not yet published full data or peer-reviewed it.

How would the COVID-19 pill help hospitals?

Oral antiviral COVID treatment would be an additional resource for health care providers trying to reduce the strain of the virus on hospitals.

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

How do Merck and Pfizer COVID-19 pills work?

In clinical trials, patients who received Merck treatment took a total of 40 pills over the course of five days. Patients who received the Pfizer treatment took a total of 30 pills over five days. Treatments should be started within five days of the onset of symptoms.

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

Merck’s Pill disrupts the way the virus copies its genetic material, causing mutations. “Eventually, so many mistakes or mutations are created that the virus just kind of dies,” Cutrell said.

Pfizer’s treatment works in a different part of the viral life cycle and instead interferes with an enzyme needed for replication. The treatment consists of two components, an experimental molecule and a drug called ritonavir, which has previously been used in HIV patients.

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

What are the limitations of the COVID-19 pills?

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

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

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

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

“Those are all important questions that we will look for as the FDA panel reviews the data and then see what decision has been made,” he said.

The Associated Press contributed to this report.

Dallas Cowboys head coach Mike McCarthy looks at the video card for a replay after the defense made a fourth-quarter stoppage against the Kansas City Chiefs at Arrowhead Stadium in Kansas City, Missouri, Nov. 21, 2021. The Cowboys lost 19-9.
From left: Nurses Kelsey O'Meara, Noelle Hackfeld and Joanna Pless assessed the oxygen levels of an intubated COVID-19 patient at Parkland Hospital's Tactical Care Unit on Feb. 10, 2021 in Dallas.