Members of the FDA’s Antimicrobial Drugs Advisory Committee voted to recommend molnupiravir, which could reduce the relative risk someone will progress to severe illness or death by about 30%. The absolute reduction in risk of serious illness or death was 3%-9.7% in those receiving placebo of death, compared with 6.8% in those receiving molnupiravir.
If licensed, the drug would be the first oral antiviral treatment to combat Covid-19. It comes in capsule form.
The medicine must be taken within five days of the onset of symptoms to work well, and people must take four tablets twice a day for five days. Committee members were worried about the risks to pregnant women.
Jennifer Le, professor of clinical pharmacy at the University of California, San Diego.
“I didn’t think I would want to take this drug, knowing the pictures,” said Roblena Walker, consumer representative on the committee and CEO of Mableton, Georgia, public health consulting group EMAGAHA Inc. its effect on my unborn baby. .
“I voted yes because Covid-19 remains an emergency. As a frontline clinician in treating patients, both inpatients and outpatients, there is a need for something like that. this,” said Dr. W. David Hardy of Charles Drew University. of Medicine and Science in Los Angeles. “While I have questions about its overall, longer-term effectiveness, it met the indicated statistical boundaries before showing a 48 percent improvement in hospitalization and mortality. ”
Most of the members said they hoped Merck would be required to continue to collect safety data about the pill.
Dr Lindsey Baden, director of clinical research in infectious diseases at Brigham and Women’s Hospital in Boston, said: “I found this to be an extremely difficult decision and, as I said, a lot of it. more questions than answers. correct.
“Overall, I trust our practitioners that if we educate them properly, they can implement this properly,” added Baden.
Committee members noted that while initial data showed the drug to be 50 percent effective in reducing the risk of severe illness and death, subsequent analysis found it to be only 30 percent effective.
Dr George Siberry, medical officer at the US Agency for International Development, who voted yes, said: “The final data set still shows a 30% decrease in hospitalization and mortality at the same rate. significantly reduced mortality.
Siberry said he believes the drug should only be prescribed to adults and that women who are pregnant or may become pregnant should be counseled about the possible risks. But Siberry said he doesn’t think high-risk pregnant women shouldn’t use the drug.
Molnupiravir is not the only antiviral drug developed to fight Covid-19. Pfizer filed to license its antiviral drug this month. The FDA has yet to set a date for its advisory panel to review the drug.
Currently, the only antiviral drug approved to fight Covid-19 is remdesivir, sold under the brand name Veklury. It is transmitted and requires medical attention. Medicines can be prescribed and taken at home.
Other Covid-19 treatments include monoclonal antibodies, which are also infused or injected and kick off an immune response to the infection, steroids to suppress the immune overreaction to the infection during the disease. and anticoagulants to prevent blood clots.
Molnupiravir interferes with the virus’s ability to replicate inside the body. It is also being studied for its ability to prevent illness in people exposed to the virus, Merck said.
The FDA will now review the committee’s recommendation. It does not have to follow the advice of the committee, but often does.
The US federal government has contracted to buy 3.1 million courses of molnupiravir for $2.2 billion, which works out to about $700 per course.
“In anticipation of outcomes from (clinical trials) and potential for regulatory approval or licensing, Merck has manufactured molnupiravir with risks and is expected to produce 10 million courses of treatment by the end of the year. 2021, with at least 20 million courses to be produced by 2022,” the company said in a statement.
“With the continued spread of the virus and the emergence of variants, additional treatments for COVID-19 are needed. That’s why we are moving with speed and urgency. rigorously to pursue authorization and accelerate global access to this investigational drug,” said Dr Dean Li, executive vice president and president at Merck Research Laboratories.
“We are grateful to the members of the Advisory Committee who reviewed our application, as well as the patients and investigators who participated in our clinical trials, and we will continue to continue to work with the FDA as it completes its review.”
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