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FDA Advisors narrowly approve Merck’s Covid-19 drug

“I’m not sure it’s really what we expected, but it’s the one we have right now,” said John Coffin, a microbiologist at Tufts University, who voted in favor of allowing the medication.

“I would use it in high-risk, unvaccinated people,” said Michael Green, an internal medicine doctor at Children’s Hospital of Pittsburgh, who also voted in favor. He expressed concern about the lack of other options for patients, especially if monoclonal antibodies are less effective against new mutations in Covid-19.

Jennifer Le, a clinical pharmacologist at the Skaggs School of Pharmacy and Pharmaceutical Sciences, voted against, citing some of the safety signals seen in these trials, particularly associated with the study’s small size and modest benefits. She said she would need to see a larger clinical trial before voting for it in the future.

An interim analysis of the results of late-stage clinical trials showed that a series of molnupiravir treatments halved hospitalization rates, although additional data released last week suggests the effectiveness is closer to 30 %. Still, the pill is a potential breakthrough in managing the pandemic, offering the prospect of a home treatment option for those at risk of developing serious illness.

“The efficacy of this product is not extremely good,” said David Hardy, scientific and medical consultant and assistant professor at the Charles R. Drew University School of Medicine and Science in Los Angeles. He also pointed out that in this particular study, the effectiveness seemed to decrease as more participants were enrolled in the study.

Many advisers have said they want to see the agency put limits on who could receive the drug and limit it to those defined by the Centers for Disease Control and Prevention as being at high risk of developing severe Covid. Some have also suggested that they want to see more stringent guidelines, limiting the criteria to the narrower list of conditions included in Merck’s advanced stage clinical trials.

“It was a very difficult decision for me. I literally rocked, like I know everyone else has, ”said Roblena Walker, CEO of a Georgia public health surveillance company, which has backed the drug for emergency use. She believes there is an issue of access for patients, who would have to go through a doctor to get a prescription. “I don’t think this study did full justice or really took into consideration this minority population who may not have full access to a primary care physician in order to receive a prescription to take the drug outside of the hospital. ‘go to the emergency room, “Walker said.

Many voting members suggested that the emergency use authorization should be reconsidered if another comparable therapy with better efficacy and safety comes out. Pfizer also has a Covid-19 antiviral pill and is seeking FDA clearance for the treatment. The agency has yet to set a date for its external committee to discuss it.

The panel recommended limiting molnupiravir to people who are pregnant or breastfeeding, unless a person’s health care provider thinks the benefit outweighs the risk. Although pregnant women have been excluded from clinical trials, data from animal studies suggests that it can lead to miscarriages or birth defects.

“There is no circumstance in which I would advise a pregnant woman to take this drug,” said James Hildreth, president of Meharry Medical College in Nashville.

“I think the best course of action has to be to provide as much information as possible as soon as it becomes available and keep it up to date,” said Janet Cragan, chief medical officer of the Birth Defects and Disorders division. infant disorders at the CDC. The FDA needs to provide talking points for providers and patients and, because the risks are so high, she said, “I think the final decision should be with the woman and her caregiver.”

Background: Molnupiravir would be the first pill authorized to treat Covid-19 and the first therapy to be authorized for mild cases. All other authorized Covid-19 treatments must be administered in a healthcare setting for more severe forms of the disease. The hope is that these pills, which are generally easier to manufacture, can reduce the burden on hospitals by ensuring the safety of individuals.

And after: The FDA will decide whether or not to approve the drug and which populations should receive it. The agency does not have to side with its advisory committee, but it often does.

Lauren Gardner contributed to this report.

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