Merck is urging U.S. authorities to approve its COVID-19 tablet, which would provide an entirely new and simple weapon used to fight against the pandemic.
It would be the first drug shown to treat COVID-19 if approved by the Food and Drug Administration. All other FDA-approved treatments for the virus necessitate the use of an IV or injection.
According to ABC News, an antiviral medication that individuals can take at home to relieve symptoms and expedite recovery could be revolutionary, easing the burden on U.S. hospitals and assisting in controlling outbreaks in poorer countries with inadequate health care systems. It would also support the pandemic’s two-pronged treatment approach (medicine) and prevention (mainly immunizations).
Before making a decision, the FDA will examine corporate data on the drug’s safety and effectiveness.
Emergency use will be granted for those adults with mild-to-moderate COVID-19 who are at risk of severe disease or hospitalization, according to Merck and its partner Ridgeback Biotherapeutic.
“The value here is that it’s a pill so you don’t have to deal with the infusion centers and all the factors around that,” said Dr. Nicholas Kartsonis, a senior vice president with Merck’s infectious disease unit. “I think it’s a very powerful tool to add to the toolbox.”
The drug manufacturer said earlier this month that it reduced hospitalizations and fatalities in people with early COVID-19 symptoms by half. The findings were so compelling that independent medical professionals overseeing the experiment suggested that it be terminated early.
Patients who took the medicine and those in a testing group who received a sham pill experienced similar side effects. On the other hand, Merck has not made public the types of issues that have been documented, which will be a significant component of the FDA’s investigation.
Vaccination remains the best approach to protect against COVID-19, according to top U.S. health officials.
Dr. Anthony Fauci said while discussing Merck’s drug last week, “It’s much, much better to prevent yourself from getting infected than to have to treat an infection.”
Despite this, 68 million eligible Americans are still unvaccinated, highlighting the need for effective medications to combat future outbreaks.
Health experts have emphasized the need for a handy pill since the outbreak began. The goal is to create something similar to Tamiflu, a 20-year-old flu treatment that reduces the severity of symptoms, including fever, cough, and stuffy nose, by a day or two.
Three FDA-approved antibody medicines have shown to be highly effective in lowering COVID-19 mortality, but they are costly, difficult to manufacture and require specialized equipment and health professionals to administer.
The U.S. government has agreed to buy enough pills to treat 1.7 million individuals, assuming FDA approval, at the cost of around $700 per course of treatment. That’s less than half the cost of antibody medications acquired by the U.S. government, which cost more than $2,000 each infusion.
In an interview, Merck’s Kartsonis stated that the $700 estimate does not represent the medication’s final pricing.
“We set that price before we had any data, so that’s just one contract,” Kartsonis said. “Obviously we’re going to be responsible about this and make this drug as accessible to as many people around the world as we can.”
According to reports, Merck, based in Kenilworth, New Jersey, has said that it is in talks with governments worldwide about purchasing its products and that it will utilize a sliding price scale based on each country’s economic resources. In addition, the company has struck licensing agreements with a number of Indian generic drug companies to create low-cost copies of the drug for low-income countries.
Pfizer and Roche, among others, are testing comparable medications and are likely to release results in the next weeks and months. AstraZeneca is also looking for FDA approval for a long-acting antibody medication that will provide months of protection for individuals with immune-system abnormalities who do not respond well to vaccination.
Some specialists believe that in the future, different COVID-19 medicines will be recommended in conjunction to better protect against the virus’s worst side effects.
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