Watch out Moderna. You are not the only game in town. This one is better.
On Monday, Merck asked US regulators to authorize its COVID-19 pill, which would add an entirely new and simple-to-use weapon to the world’s arsenal against the pandemic.
If authorized by the Food and Drug Administration, which may happen in a matter of weeks, it would be the first drug shown to treat COVID-19. All other FDA-approved treatments for the disease necessitate the use of an IV or injection.
An antiviral drug that patients may take at home to alleviate symptoms and speed recovery could be a game-changer, reducing pressure on U.S. hospitals and assisting in the management of epidemics in poorer countries with undeveloped healthcare systems. It would also enhance the pandemic’s two-pronged treatment and prevention strategy, primarily through vaccinations.
The FDA will evaluate corporate data on the safety and effectiveness of the drug, molnupiravir, before reaching a decision.
Merck and its partner Ridgeback Biotherapeutic asked the FDA specifically for emergency use for patients with mild-to-moderate COVID-19 who are at risk of serious illness or hospitalization. That is roughly how COVID-19 infusion medications are given.
“The value here is that it’s a tablet, so you don’t have to deal with infusion facilities and all that,” Dr. Nicholas Kartsonis, senior vice president of Merck’s infectious disease unit, explained. “I feel it is a really powerful weapon to have in your arsenal.”
The company said earlier this month that the pill cut hospitalizations and deaths in people with early COVID-19 symptoms in half. The findings were so convincing that the trial, which was overseen by independent medical specialists, was called off early.
The adverse effects were comparable across individuals who got the drug and those in a control group who were given a bogus pill. Merck, on the other hand, has not publicly stated the types of problems that have been found, which will be a critical element of the FDA’s inquiry.
Vaccinations, according to US officials, are the most effective way to protect against COVID-19. However, with around 68 million eligible Americans still refusing vaccinations, effective medications will be critical to minimizing future outbreaks of disease.
Since the outbreak’s inception, health officials have stressed the need of having a portable tablet. The goal is to develop something similar to Tamiflu, a 20-year-old flu medication that shortens the illness by a day or two while also decreasing the severity of symptoms including fever, cough, and stuffy nose.
Three FDA-approved antibody medications have proven to be highly effective in reducing COVID-19 deaths, but they are expensive, complex to manufacture, and need specific equipment and health professionals to deliver.
In the event that the FDA approves, the US government has committed to purchasing enough pills to treat 1.7 million patients at a cost of about $700 per course of therapy. That’s less than half the price of the antibody drugs obtained by the US government — more than $2,000 per infusion — but still more than many antiviral pills used to treat other infections.
In an interview, Merck’s Kartsonis indicated that the $700 figure does not represent the drug’s final price.
“That cost was determined before we had any data,” Kartsonis stated, “so that’s just one contract.” “Of course, we’re going to be responsible about it and make this treatment available to as many people as possible all around the world.”
Merck, headquartered in Kenilworth, New Jersey, has claimed that it is in purchase negotiations with governments throughout the world and will use a sliding pricing scale based on each country’s economic means. Furthermore, the company has entered into license arrangements with a number of Indian generic pharmaceutical manufacturers to create low-cost versions of the drug for low-income countries.
Several other companies, including Pfizer and Roche, are studying comparable drugs and will report their findings in the coming weeks and months. AstraZeneca is also asking FDA permission for a long-acting antibody drug that is intended to provide months of protection for those who have immune system disorders and do not respond well to immunization.
Some experts believe that numerous COVID-19 therapies will be used in tandem in the future to better protect against the virus’s worst effects.
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