Here are seven things to know about the drug:
- The pill was developed at Emory University in Atlanta. It was funded by $35 million in taxpayer grants, according to...
- When the pandemic began, the university licensed molnupiravir to Ridgeback Biotherapeutics so the drug could be tested...
- In May 2020, Merck bought the exclusive rights to sell and manufacture the pill...
Full Answer
What makes Merck’s pill unique?
What makes Merck’s pill unique is that a patient's primary care doctor can prescribe it, they can pick it up later that day, and start their treatment at home. This could alleviate some of the capacity issues impacting hospitals across the country.
Will Merck’s molnupiravir be approved by the FDA?
Merck has applied to the Food and Drug Administration (FDA) for emergency use authorization (EUA) of the pill, called molnupiravir. An advisory committee is scheduled to evaluate the safety and efficacy data of the pill on Nov. 30 and decide whether to approve it for EUA in the United States.
Could Merck's antiviral pill be the first approved at-home medication?
But Merck's pill is farther along in the process and could become the first antiviral drug approved to be taken orally and at home with a prescription. (See below for more on other antiviral drugs.)
Is the Merck trial safe for pregnant women?
He advised caution with widespread use until more data is available, due to its potential harm to young people of reproductive age or those who are pregnant. The Merck trial currently excluded pregnant women.
How does Merck's COVID-19 treatment pill work?
It works just like most antivirals by inhibiting the ability of the SARS-CoV-2 virus to replicate. The hope is that we can treat COVID-19 the way we do influenza with Tamiflu, the antiviral medication used to prevent serious flu symptoms.
What makes Merck's pill different from other COVID-19 treatments?
Currently, all COVID-19 therapies now authorized in the United States require an IV or injection, requiring patients to be in the hospital or an infusion center. As an example, monoclonal antibody treatments are given to patients through an IV infusion or injection, so they need to come to a clinic or hospital.
Who will be eligible to receive Merck's pill if it is approved?
For almost anyone over 18 years old, this could be a potential treatment option for COVID-19. High-risk adults, people 60 and over or those who are younger but have conditions that put them at high risk of bad outcomes from COVID-19, may benefit the most.
When would it be best to start taking Merck's pill?
With the doctor's approval, patients should start taking the pill as soon as they test positive for COVID-19. The earlier a patient receives an antiviral, the more effective it will likely be.
Merck is allowing drug makers in other countries to make its COVID-19 pill. Why is this important?
I think this will really increase the amount of the treatment available and bring down the costs as well. Mainly, it increases the availability to people that might need it, especially in poorer countries. The more we curb the spread of COVID-19 throughout the globe, the less it will replicate and make this treatment more effective.
Who will get the pills?
The pills are meant for people who are sick with Covid but are not in the hospital. Merck’s Phase 3 clinical trial enrolled only unvaccinated people who were considered high risk, such as older people or those with medical conditions like diabetes or heart disease.
How effective are they?
Merck said the drug cut the risk of hospitalization or death in half. In the Phase 3 trial, 7 percent of volunteers in the group that received the drug were hospitalized, and none died. In the group that got a placebo, 14 percent were hospitalized or died.
When will the pills become available?
Merck said on Friday that it plans to seek emergency authorization from the Food and Drug Administration as soon as possible. Regulators could then authorize the drug before the end of this year, if all goes well.
Will there be enough pills?
Merck expects to be able to make enough pills for 10 million people by the end of this year. The U.S. government has already ordered 1.7 million courses of treatment.
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How much will the treatment cost?
The federal government is paying about $700 per course of treatment. That is about one-third of the cost of a monoclonal antibody treatment. The plan is to make the pills free for Americans, like the Covid vaccines. Whether there are any out-of-pocket costs is likely to be determined after the pills are authorized for use by regulators.
What is Merck's COVID pill?
Merck's antiviral pill can help those infected with the COVID-19 virus, lessening the effects of the illness, regardless of whether you are vaccinated or not. And the oral drug is expected to be effective against variants, including the new omicron virus mutation.
When will Merck's oral pill be available in the US?
The drug could soon be available if federal regulators don't turn up any problems, The New York Times reported .
Is it just one COVID antiviral pill or a bunch of them?
A course of the drug would require taking molnupiravir twice a day for five days. In total, a course would include taking 40 pills.
Does swallowing a pill mean you don't need a COVID-19 vaccine?
Vaccines and antiviral drugs could work together but serve different purposes. A vaccine is intended to provide powerful protection to keep you from getting COVID-19. An antiviral drug helps your body fight a virus if you get infected.
Will Merck's antiviral treatment be free?
That's the plan. Merck said the US government will buy 3.1 million courses of the drug to provide for free if and when it is approved, much as it does now with the three approved vaccines from Pfizer, Moderna and Johnson & Johnson.
What do we know about eligibility for Merck's antiviral pill?
In its tests, Merck's molnupiravir pill was given to people who were unvaccinated and had tested positive with mild to moderate COVID-19 but were not hospitalized.
What do we know about the COVID pill's side effects?
A Merck spokesperson said the incidence of drug-related side effects during the drug's trials was comparable between the group that received molnupiravir and the one that took the placebo -- 12% and 11%, respectively.
How does it work?
The new drug targets the machinery that the coronavirus uses to make copies of itself — it introduces errors into the virus’ genetic code.
How does it compare with the other treatments for COVID-19?
Once COVID-19 patients are sick enough to need a hospital, one way to treat them is to stop the virus then, said Thomas Fekete, an infectious disease specialist and chair of medicine at Temple University.
What questions do doctors still have?
Chaparro said Merck’s press release on molnupiravir included details about the drug’s efficacy, but he would like to see more details about safety. He noted that the drug works by interfering with the machinery that the virus uses to make copies of itself, and that, in theory, this could affect similar machinery in humans as well.
What happens next?
The federal government has already bought doses of the drug. The Department of Defense announced back in June that the drugmakers have a contract for more than a million courses. But the FDA still needs to review the data and grant emergency use authorization before doctors can start using it on COVID-19 patients.
What does this mean for the pandemic overall?
Fekete, at Temple, said people will often see a new COVID-19 medicine and wonder if it can slow the virus and epidemic down significantly. He said that the new drug has the potential to slow down transmission from people who are already diagnosed, which is useful, but “it’s not going to be a game-changer.”
How many other anti-COVID pills will end up proving effective?
One of the reasons that the success of molnupiravir is such a big deal is that there were questions as to whether an antiviral pill could help COVID-19 patients if given early enough. This medicine certainly did, reducing hospitalizations by 50%; it also appeared to have an impact on whether patients survived. That makes it a game-changer.
How safe is molnupiravir?
Obviously, a drug given early in COVID needs a clean safety profile. So far, the data included in the press release look very good. Patients in the placebo arm were three times more likely to withdraw from the study due to apparent side effects than those who actually received molnupiravir.
Could there be other effects?
In a conference call with reporters, Daria Hazuda, a top Merck virologist, said that Merck and Ridgeback had studied the mutagenic potential of the drug in both cell lines and in animal models that are routinely used in drug development and which are accepted by regulatory agencies.
So how big will the market be?
Daina Graybosch, an analyst at SVB Leerink, forecast in a note to investors that molnupiravir sales will peak near $5 billion a year in 2022.
What will it cost and who will pay?
Most analysts are basing the cost of molnupiravir on the $1.2 billion the U.S. government spent to lock up 1.7 million courses of the medicine, which works out to $700 per five day course. But Anderson points out that the cost for a new pill to treat influenza developed by Roche is just $150 per course. Will the $700 price hold up?
How will the availability of COVID pills affect vaccines and other treatments?
It doesn’t make any sense to forego a COVID vaccine because a pill to treat the disease exists. The benefits are additive, and someone who got a breakthrough infection and then the pill has a much lower risk of hospitalization than someone who just relied on the pill.
How does this treatment relate to ivermectin?
This is simple: it doesn’t. But it’s worth taking a look at what data are available for each.
