The American pharmaceutical giant Merck, from the company MSD, reported on Monday that it has requested the United States health authorities to authorize the emergency use of an oral drug to treat COVID-19.
The tablet is called molnupiravir, “An investigational oral antiviral drug for the treatment of mild to moderate COVID-19 in adults who are at risk of progressing to severe COVID-19 and / or being hospitalized,” the company said in a statement.
If approved by the U.S. Food and Drug Administration (FDA) – a decision that could be made in a matter of weeks – it would be the first pill proven to treat COVID-19.. All other FDA-supported disease treatments require an injection or IV.
An antiviral pill that people could take at home to reduce their symptoms and speed up their recovery it would be a momentous advance that would reduce the burden on American hospitals and help fight outbreaks in poorer countries with vulnerable medical systems, though its price is not cheap. It would also reinforce the strategy on two fronts of the pandemic: treatment with medication and prevention, especially through vaccines.
The FDA will study the company’s data on the drug’s safety and effectiveness before making a decision. Merck and its partner Ridgeback Biotherapeutic reported specifically requested that the FDA authorize emergency use for adults with mild to moderate cases at risk of developing a severe condition or being hospitalized.
“The value here is that it’s a pill, so you don’t have to deal with infusion centers and all the factors around that,” said Dr. Nicholas Kartsonis, a senior vice president of Merck’s infectious diseases unit. “I think it is a very powerful tool to add to the options.”
The company reported earlier this month that the pill cut hospitalizations and deaths in half among patients with early symptoms of COVID-19. The results were so compelling that the independent medical experts who supervised the trial recommended stopping it sooner.
Side effects were similar between patients who received the drug and those in a test group who received a dummy pill. But Merck has not publicly detailed the types of problems recorded, which will be a key part of the FDA’s review.
US authorities continue to promote vaccination as the best way to protect against COVID-19. Nevertheless, Since some 68 million eligible Americans still do not want to be vaccinated, the effectiveness of the drugs will be critical to controlling future waves of infection.
Since the beginning of the pandemic, health experts have insisted on the need for a convenient pill. The goal is to achieve something similar to Tamiflu, the 20-year-old anti-flu medicine that shortens the illness by a day or two and lessens the severity of symptoms such as fever, cough, and nasal congestion.
Three FDA-cleared antibody drugs have been shown to be highly effective in reducing COVID-19 deaths, but they are expensive, difficult to produce, and require special equipment and healthcare professionals to administer..
Assuming the FDA clears them, the US government has agreed to buy enough pills to treat 1.7 million people, at an approximate price of $ 700 for each treatment. That’s less than half the price of anti-antibody drugs purchased by the US government – more than $ 2,000 per infusion – but it is still more expensive than many antiviral pills for other diseases.
Merck’s Kartsonis said in an interview that the $ 700 figure would not represent the final price of the drug. “We set that price before we have data, so it’s just a contract,” Kartsonis said. “Obviously, we are going to be responsible about it and make this medicine accessible to as many people as possible around the world.”
Merck, based in Kenilworth, New Jersey, has stated that it is in purchasing talks with governments around the world and that will use a price scale based on the economic means of each country. In addition, the company has signed licensing agreements with several Indian generic drug manufacturers to produce low-cost versions of the drug for lower-income countries.
Other companies, such as Pfizer and Roche, are studying similar drugs and are expected to present results in the coming weeks and months. AstraZeneca is also seeking FDA clearance for a long-acting antibody drug intended to provide months of protection to patients with immune system disorders who do not respond adequately to vaccination.
Over time, some experts envision multiple COVID-19 therapies being prescribed in combination to better protect against the worst effects of the virus.
(With information from AFP and AP)