SOUTHFIELD, Mich. (FOX 2) - The drugmaker Merck will seek emergency use authorization for the first of its kind pill to fight COVID-19 and doctors believe this could change the fight against the deadly virus.
Merck & Co. said Friday that its experimental COVID-19 pill reduced hospitalizations and deaths by half in people recently infected with the coronavirus and that it would soon ask health officials in the U.S. and around the world to authorize its use.
If cleared, Merck's drug would be the first pill shown to treat COVID-19, a potentially major advance in efforts to fight the pandemic. All COVID-19 therapies now authorized in the U.S. require an IV or injection.
Beaumont's Director of Infectious Disease Research, Dr. Matthew Sims, said the early results of Merck's pill could have a lasting impact on COVID-19.
"This pill will help. This pill reduces hospitalizations by about 50% and it seems to prevent deaths even more," Dr. Sims said. "In the placebo group, there were eight deaths. In the treatment group, there were no deaths. That’s impressive. This is wonderful news."
Merck and its partner Ridgeback Biotherapeutics said early results showed patients who received the drug, called molnupiravir, within five days of COVID-19 symptoms had about half the rate of hospitalization and death as patients who received a dummy pill. The study tracked 775 adults with mild-to-moderate COVID-19 who were considered higher risk for severe disease due to health problems such as obesity, diabetes or heart disease.
Among patients taking molnupiravir, 7.3% were either hospitalized or died at the end of 30 days, compared with 14.1% of those getting the dummy pill. There were no deaths in the drug group after that time period compared with eight deaths in the placebo group, according to Merck. The results were released by the company and have not been peer reviewed. Merck said it plans to present them at a future medical meeting.
The treatment would require patients to take four pills twice a day for five days.
"Basically the antivirals work by preventing the virus from replicating withinin the cells," Dr. Sims said.
This is the first drug to fight COVID-19 that is not administered via vaccine or IV.
"The problem with remdesivir is that it’s only IV. You can't just start it as an outpatient," Dr. Sims said. "This is a pill so it can be prescribed and given us an outpatient. That's going to make it much easier to use."
But Dr. Sims said it needs to be clear that if you catch Covid, it doesn't mean you would be a good candidate for drug treatment. Treatment with the pills work best when the virus is in its early stage.
"It’s been studied early on, within five days of symptoms first occurring, and in mild to moderate so this isn’t for the people who are already really sick," Dr. Sims said. "Antiviral drugs really need to target it early to stop the virus before it goes on to pneumonia before it goes on to hyperinflammation and us with this drug is meant for."
A decision from the Food and Drug Administration could come within weeks and if it gets the green light, distribution could soon follow.
But Dr. Sims stresses this is not a replacement for the COVID-19 vaccines and that's still the safest route to go.
"It’s not enough. Just like we tell everybody to get the flu shot even though there’s Tamiflu out there, it’s important to take the vaccine even though this pill may be out there," Dr. Sims said.
Information from the Associated Press was used in this report.