The FDA's expert panel voted Tuesday in favor of approving the treatment for COVID-19, which is a pill to treat the disease.
The thumbs-up was not without controversy, as several panelists raised concerns over the drug's safety risks and modest efficacy levels. The benefits outweigh the risks of using the drug for people who are at high risk of severe disease who are within five days of symptoms.
Several voting members wanted to exclude pregnant women from being authorized.
"I think the FDA should not approve it for use in pregnant women except under really exceptional circumstances," said David Eastman, a biology professor at University of California, Riverside, who voted yes.
I think they should limit it to high-risk individuals.
The decision should be left to the pregnant person and a medical counselor, according to others.
"As a woman of child-bearing age, I don't think I would want to take this drug, not knowing the effects it could have on my unborn child," said Roblena Walker, a consumer representative selected to advise the committee. She voted yes because the drug's risks and benefits will be further weighed.
The FDA is considering whether to grant an emergency use authorization for the drug molnupiravir. The agency doesn't have to follow the advice of its expert panel.
More than 1,400 people who recently got COVID-19 were part of the clinical trial. Volunteers were randomly given either a 40-pill regimen or dummy pills.
The drug reduced hospitalizations and deaths by 30 percent. The figure took experts and analysts by surprise, as an interim analysis showed a 48 percent reduction.
Several safety concerns with the drug were highlighted by the FDA. The agency noted several risks, including the risk to fetuses.
The risks come from the drug being a nucleoside, a type of antiviral that inserts errors into the copying process of a virus. This makes it hard for the virus to replicate itself. The theoretical risk of the drug interacting with human cells is being debated by scientists.
Some voting members decided the risks were more important than the benefits.
The effect on the total trial population was modest according to Dr. Sankar Swaminathan, an infectious-disease expert at the University of Utah Health.
The risk of mutagenic effects on the patient is not firmly established or characterized, and given the large potential population affected, the risk of widespread effects on potential birth defects and especially delayed effects on the male has not been adequately studied.
The first COVID-19 pill could be a drug from Merck.
If approved, molnupiravir would be the first pill to treat COVID-19, an advance that could simplify and expand access to medical care for patients. Several antibody therapies are expensive and can require a lengthy IV injection.
It was originally developed as a treatment for the flu. The drug was licensed by Ridgeback Biotherapeutics in July 2020.
The federal government is betting big on a drug. The US agreed to pay US$1.2 billion for 1.7 million pills to treat 1.7 million people. In November, it secured another deal to get another 1.4 million treatment courses. The deals are contingent on the FDA approving the treatment.
Analysts think the pill may not be popular. When other treatment options aren't available, it will be used most of the time, according to a Monday research note from a analyst.
Pfizer's COVID-19 pill has higher efficacy and is not as safe as molnupiravir.
Better drugs are on the way.
There is room for improvement from the drug.
"If there's an alternative therapy that's effective, like a future medicine, that would be the priority," said Dr.
In a similar patient population, Pfizer's pill reduced hospitalizations and deaths by 89 percent. That drug doesn't carry the same risks as the one that Merck has, because it blocks anidase that plays a key role in the virus' copying process.
Wall Street analysts think Pfizer's pill will be a blockbuster drug. Morgan Stanley expects US$26 billion in sales in 2022, while SVB Leerink expects US$ 24 billion. Pfizer's drug is being reviewed by the FDA.
The pill could be an option for people with a high risk of developing COVID-19. John Coffin voted yes with the suggestion that the initial authorization be reserved for high-risk groups, like individuals older than 60 who have not been vaccine-free.
"I'm not sure if this is the one we've been waiting for, but it's all we have at the moment," Coffin said.
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