The medicine pill is displayed on a screen in the background with the words 'Molnupiravir' and 'COVID-19' written on it.
Despite questions about the drug's effectiveness, safety and whether it would help the virus evolve into even more dangerous variant, the FDA advisory panel endorsed the oral Covid treatment pill.
The FDA's Antimicrobial Drugs Advisory Committee voted 13 to 10 to recommend emergency authorization of molnupiravir, an oral antiviral drug that was initially hailed as a potential game-changing weapon in the battle against Covid. It is designed to treat adults with mild to moderate symptoms of Covid-19 who are at high risk of severe disease. The pill is taken every 12 hours for five days.
The drug needs final approval from the FDA and CDC before it can be used by the public. The FDA does not have to listen to the panel.
A full set of data presented to the FDA on Tuesday shows that the drug is just 30% effective in preventing hospitalizations and death.
The drug is not recommended for use in children and pregnant women. The drug was found to cause birth defects and reduce fetal body weight. The data shows that it also caused other defects that interfered with bone growth in young pups.
Covid is prevented from replicating and spreading by the virus that causes it to mutate. Doctors and scientists worried that it could allow the virus to change in a way that makes vaccines and treatments less effective.
If the drug causes an escape Mutant from which the vaccines we don't cover, that could be catastrophic for the world.
Nicholas Kartsonis, the senior vice president of clinical research at the company, said that they don't have data on the chances of a variation evolving. Kartsonis noted that the spikeprotein, which the virus uses to attach to human cells, has not been changed more in the placebo group than it has in the clinical trials. Hildreth told Kartsonis that it was incumbent on the company to estimate the likelihood of escape.
We are looking into the possibility of using the currently available public SARS CoV-2 to sequence databases to monitor for the emergence of novel variant in the replicase complex as well as the spike proteins.
The FDA's senior virology reviewer said it was unclear if changes to the spike protein associated with molnupiravir could have a significant impact on the evolution of the virus.
It is not known if the molnupiravir variant can affect the evolution of sars-coV-2 beyond a treated individual.
The FDA approved molnupiravir on an emergency basis. No anti-viral drugs have been approved to treat Covid. Pfizer wants to sell its own oral Covid treatment pill that it claims is 89% effective in preventing hospitalization and death when used with a popular HIV drug.
The pill was 50% effective at reducing the risk of hospitalization or death in an interim analysis of 762 patients, according to the initial application and presentation to the FDA. The company said that the analysis of the full population showed a lower efficacy rate.
The group that took the pill had a higher hospitalization and death rate than the placebo group.
The FDA committee was told by Kartsonis that the drop in hospitalization and death in the placebo group compared to the molnupirivar group doesn't add up.
The second part of the study involved patients with older age and more diabetes. It would have been thought that you would see more mortality.
There were more women in the second part of the study, and that has been associated with less risk, as well as more patients who were positive for the immune system.
Unvaccinated adults who were older than 60 and had pre-existing conditions such as diabetes, obesity, and heart disease were more likely to be in the trial.
The interim analysis of 762 participants showed that molnupiravir significantly reduced the risk of hospitalization or death, with nine out of 10 deaths occurring in the placebo group.
According to Kartsonis, there were no safety concerns associated with the clinical trial. He said that a small number of patients experienced nausea and dizziness.
As we enter the winter months, another surge is imminent, potentially in the setting of emerging variant of concerns, as our hospitals currently have more than 50,000 Americans struggling with this disease. He said that we need novel effective well-tolerated and conveniently administered therapies to treat COVID 19′′ in outpatient settings.
The drug can result in reduced fetal body weight and abnormal bone formation according to FDA scientists. The clinical trial did not include pregnant women.
The FDA told the advisory panel that molnupiravir could cause harm to human fetuses if it is administered to pregnant women. The abnormal bone and cartilage formation observed in animals is not relevant to adult humans, according to Seaton.
It wouldn't be ethical to prescribe molnupiravir to a pregnant woman who is suffering from Covid if the drug isn't available in the US, according to Dr. Janet Cragin, a medical officer at the CDC's birth defects division.
Cragin said that her views don't represent the CDC, and that she wasn't sure if she could ethically tell a pregnant woman that she couldn't have the drug if she wanted it.
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Dr. Hildreth was the CEO of Meharry Medical College.
Do we want to reduce the risk for the mother by 30% while exposing the embryo and fetus to much higher risk of harm by using this drug? Hildreth said that his answer was no. There is no circumstance in which I would advise a pregnant woman to take this drug.
Robert Heflich, director of the FDA's genetic and molecular toxicology division, said the risk of molnupiravir altering human genes in a clinical setting is low. The study did not show an increase in the number of animals with the same genes.
The study was conducted after a previous investigation using rodents that were not sure if molnupiravir is mutagenic. During in situ investigations, molnupiravir was found to be mutagenic.
The data on whether molnupiravir is associated with genes was a point of contention during the public comment portion of the meeting. The basis for the conclusion about potential human risk was raised as a concern by some experts and members of the public. The FDA believes that the risk of genes changing is low because of the short treatment period.
