FDA Advisors Ready to Discuss Merck’s Covid Pill


As the world is shaken by the emergence of the Omicron variant of the coronavirus, a panel of advisors to the Food and Drug Administration let’s meet on tuesday To discuss an antiviral pill from Merck, which is the first in a new class of treatments that can work against a wide variety of variants.

expert committee, vote whether it would be advisable to allow the drug known as molnupiravir for high-risk patients. Treatment – predominantly shown to modestly reduce the risk of hospitalization and death. Delta, Mu and Gamma variants — may be allowed in the United States within days and may be used shortly if the committee approves the drug and the agency follows the recommendation. Panel meeting on Tuesday It is scheduled to start at 9 a.m. Eastern time and can be viewed here.

In the coming weeks, the FDA may also greenlight a similar Pfizer pill that appears to be significantly more effective than Merck.

Health authorities around the world are relying on new treatments to reduce the number of serious cases and save lives. If Omicron causes an increase in serious infectionscan make them even more important.

Scientists have yet to conduct experiments to see how well the pills inhibit the replication of Omicron viruses. But even if the variant can sometimes evade vaccines, there is reason to think they will remain effective.

Omicron more than 30 mutations on the so-called spike protein that clings to human cells. Some of these mutations can make it harder for the antibodies produced by the vaccine to attack the virus.

But the pills do not target the spike protein. Instead, they weaken two proteins involved in the virus’s replication mechanism. Omicron carries only one mutation in each of these proteins, and neither seems to stop the pills from doing their job.

virus cases rising In many parts of the United States, particularly the Upper Midwest and Northeast. Nationwide, cases rose Since early November, the Omicron variant has raised fears over a winter wave fueled by closed holiday gatherings and tens of millions of Americans’ refusal to get vaccinated.

In a clinical study, molnupiravir found to be reduced by 30 percent Risk of hospitalization or death when given to high-risk, unvaccinated volunteers within five days of starting symptoms. It appears to be significantly less effective than the Pfizer pill, which was found to reduce risk by 89 percent, and monoclonal antibody treatments, which were found to reduce it by at least 70 percent.

If molnupiravire is allowed in the United States, the supply is expected to be limited at first, although it will be more plentiful than the Pfizer pill. The Biden administration has ordered adequate treatment courses for 3.1 million people at about $700 per person. Merck is expected to supply these pills before February.

The treatment is given within five days of the onset of symptoms and taken as 40 pills for five days.

The FDA advisory panel, a group that specializes in antimicrobial drugs, will vote on whether to allow treatment for people with Covid who are at high risk of becoming seriously ill. This will include tens of millions of Americans who are older or have medical conditions such as obesity, diabetes or heart disease.

The panel is also set to dispute Safety concerns that some scientists have voiced about the Merck pill. The treatment works by adding errors to the virus’s genes. Some scientists say there is a theoretical risk that it could trigger mutations in cells, potentially causing reproductive damage or long-term cancer risk.

Merck says laboratory tests and clinical trial data show the drug is safe and does not cause alarming mutations in humans.

England, which authorized Merck pill Earlier this month, it was recommended that it should not be given to pregnant or breastfeeding women, and that women who could become pregnant should use contraception while taking the drug and for four days afterward. FDA panel will discuss Whether there are certain situations during pregnancy where the drug may be appropriate.



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