FDA advisory group to review safety and efficacy of Merck’s Covid pill
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On Tuesday, key advisors from the Food and Drug Administration will meet to discuss whether or not to give emergency authorization to Merck for Merck’s experimental medication to treat Covid-19.
Before deciding whether the drug has any overall advantages over its potential risks, members of the FDA’s Antimicrobial Drugs Advisory Committee scrutinize data from the company. Although the FDA does not have to adhere to this advice, it will often follow its lead.
Merck asked the FDA in October to clear its drug, called molnupiravir, for use in adults with mild-to-moderate Covid-19 who are at risk for severe disease or hospitalization. This would make it the first antiviral drug to be approved for emergency use. The FDA approves only IV and injection as an alternative treatment.
The results were released by Friday Merck showed the drug reduced the risk of hospitalization and death among high-risk Covid patients by 30 percent. That’s down from an estimate of 50 percent the company made in October, and lower than currently authorized monoclonal antibody treatments, which have been shown to reduce the risk of severe outcomes from Covid by at least 70 percent.
FDA scientists have also reported potential risks of the drug, particularly to pregnant women, as animal studies suggest it could cause harm to the fetus or possible birth defects. However, these risks weren’t observed during clinical trials. Merck exempted pregnant women from the study. All participants were required to use contraception, according the agency.
The drug — developed in partnership by Merck and Ridgeback Biotherapeutics — works by introducing errors, or mutationsIt is inserted into virus genetic material to make it hard for virus replication. Pfizer developed another antiviral drug that blocks the enzyme required for replication. This pill is different. Researchers say that both medications must be used in the initial stages of the disease. Participants in Merck’s Merck study were administered the drugs within five days of their onset.
David Boulware is an infectious disease doctor at the University of Minnesota Medical School. He said that he expected the committee to recommend molnupiravir as a treatment for high-risk individuals. While the efficacy of the drug was found to be “substantially” lower than previously estimated, it could still be helpful, he said.
Doctors will still want to recommend monoclonal antibody therapy. He said they are better. He said, “But, they’re still kind of an alternative for people who don’t have access or are unable to afford those treatments.
Boulware stated that the convenience of being able prescribe medication at any hour of the day or weekend and then have the patient go directly to the pharmacy to get the prescription. Monoclonal antibodies treatments that require infusions, such as monoclonal antibody therapies, are more likely to have a higher uptake than a single pill.
Boulware indicated that Merck’s drugs could be in high demand at first. Federal government officials are working with Merck to address this issue. has agreed to purchase about 3.1 million courses of molnupiravir for $2.2 billion, with the option to buy more.
After the expected authorization, the potential for decreased demand could result in a decrease in the supply Pfizer’s oral antiviral treatmentHe stated that the use of cipro has been proven to lower mortality and increase hospitalization rates by as much as 89 percent.
There were no significant safety concerns in clinical data from Merck’s Pill. But, it may raise the rate of virus spike protein changes, FDA reported.
Merck’s safety data, which contained 593 individuals, was also noted by the agency. This is in stark contrast to other approved therapies for mild-to moderate Covid.
Ronald Swanstrom is a professor of biochemistry at the University of North Carolina School of Medicine. He said that he hopes the FDA Committee will discuss the long-term effects of the drug’s use, as well as the possible impact on the human genome.
His colleagues and he published a study in The Journal of Infectious Diseases this year that found that a byproduct of the drug induced low levels of mutations in the DNA of animal cells, suggesting it could pose a risk of cancer. Merck later pushed back on the study.
Swanstrom admitted that the mutations might be trivial. Swanstrom acknowledged that every time you visit a dentist’s office, there are X-rays going through your head. This is causing DNA damage. Our experience is not sufficient to improve any health outcome.
He said that Merck has no information about the risk of using its drug.
He said, “We need to be cautious about who we give this drug to.” He suggested that a group of people should form and determine the long-term effects.
Expert at Children’s Hospital Philadelphia and vaccine specialist, Dr. Paul Offit said while vaccination is the most effective form of defense against the disease, Merck’s pills could prevent the spread of the virus in people who are already infected. This would also help to avoid hospital visits. But he said that he is concerned about possible side effects.
Additionally, he stated that it is unlikely that the approval of the pill would influence unvaccinated individuals to receive their shots. He stated that most of them decided to get the vaccines years ago.
He stated, “I feel at this stage if your choice not to get vaccines is making you entrenched.” There’s no way to convince you of this.
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