The pharmaceuticals firm Merck asked the US Food and Drug Administration on Monday to authorize its new anti-COVID pill.
If authorized for emergency use or fully approved for general use, the pill would be a powerful means of fighting the infection in those who already are suffering from the virus.
Its ease of use and transport would make it a game-changer in the ongoing battle against the disease worldwide.
Experts believe that the FDA decision could come within a matter of weeks, rather than months, which would be a great help to the healthcare providers as they deal with the Delta variant.
Thus far, all other coronavirus treatments that the FDA has either approved or given emergency use authorization for have necessitated either an injection, in the case of the Pfizer, Moderna or Johnson & Johnson shots, or an IV, in the case of remdesvir.
In addition, the Monupiravir tablets could even be taken at home, allowing those suffering from the disease to stay away from already-overburdened hospitals.
The tablet is not seen as a standalone in the fight against Covid-19 but as a second prong in the battle, along with vaccinations.https://greekreporter.com/2021/09/26/greece-orders-probe-on-covid-19-misinformation-in-social-media/
The FDA will now study all the testing data supplied by the company regarding the effectiveness and the safety pf the pill before any approval is granted.
Merck treatment consists of five-day regimen of 40 pills
As part of asking the regulatory authority to study its use, Merck and its partner Ridgeback Biotherapeutic specifically asked the FDA to grant emergency use for adults with mild-to-moderate COVID-19 who are at risk for severe disease or hospitalization, according to a report from the Associated Press.
At present, that is the cohort that receives infusions of remdesvir to fight the infection.
Dr. Nicholas Kartsonis, a senior vice president with Merck’s infectious disease unit, told interviewers that “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.
“I think it’s a very powerful tool to add to the toolbox.”
The trial for Molnupiravir showed such promising results that independent experts monitoring it advised that the company stop the study immediately so that the medication could be placed before the FDA as soon as possible.
Merck reported at that time that the pill cut hospitalizations and deaths by half among patients who had early symptoms of Covid-19.
The side effects of Molnupiravir were similar in those patients who received the drug and those in a control group who received a placebo. Unfortunately, Merck has not disclosed exactly what those side effects were. This aspect of the drug will be studied by the FDA in its thorough review.
Still, health officials are adamant that any future approval of the Merck anti-Covid pill create a nonchalant attitude toward vaccination against Covid-19, stating that inoculations are still the best way to protect yourself against the virus.
Dr. Anthony Fauci stated regarding the Merck’s drug last week “It’s much, much better to prevent yourself from getting infected than to have to treat an infection.”
While overall, 187.7 million Americans are now fully vaccinated, representing a percentage of 56.5% of the total population, 68 million others are still unvaccinated, including those who are still ineligible.
Array of potential treatments appear on horizon after Delta variant peaks
But the Delta variant, which has wreaked so much havoc all across the world, causing hospitals to reach capacity in some areas, the number of new coronavirus cases has now dropped below 100,000 for the first time in more than two months.
The number of deaths associated with the virus are now approximately 1,700 per day, down from a total of 2,000 per day just three weeks ago.
These encouraging figures come at a time when many previously unvaccinated people appear to be changing their minds and accepting the inoculation, with the number of shots per day in the US now over 1 million.
However, these positive developments come at a time when lower temperatures make more people spend more time indoors and children — including those too young to be vaccinated — are back in school.
Experts liken Merck’s anti-Covid pill to Tamiflu, the oral medication used to fight influenza, which was introduced twenty years ago. It does not allow patients to avoid getting the virus but it shortens the duration of the illness and lessens the severity of flu symptoms.
The three FDA-authorized inoculations are expensive, take specialized equipment to produce and in the case of the Pfizer and Moderna shots, need deep refrigeration to keep their effectiveness, making the Merck drug even more welcome in the fight against Covid-19.
The U.S. government has already agreed to buy enough of the Merck anti-Covid pills to treat 1.7 million people; this comes out to approximately $700 for each patient.
This is less than half of the price of antibody drugs that were purchased by the government, which came to over $2,000 per infusion; however, it is still more than the cost of many other antiviral pills.
Kartsonis told the Associated Press that in addition, this $700 is not the total cost of the medication.
“We set that price before we had any data, so that’s just one contract,” Kartsonis said of the figure, adding “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.”
Merck, based in Kenilworth, New Jersey, is in talks with national medical authorities around the world for purchase agreements for the pill.
The pharmaceuticals firm said that it and will use a sliding price scale based on each country’s ability to pay. In addition, Merck officials stated it has already signed licensing agreements with several generic drugmakers in India to allow for the production of low-cost versions of the drug to be used in developing countries.
The Pfizer company, which was the first to produce an approved coronavirus vaccine, along with Roche, out of Switzerland, are set to release the findings of their own trials of anti-Covid pills in the next months.
The AstraZeneca corporation out of England is also asking the FDA to authorize a long-acting antibody drug that they hope will provide months of protection for those suffering from immune-system disorders, who do not have an adequate response to inoculations.
In the future, a cocktail of different Covid-19 therapies and treatments may be used to fight off the most severe forms of the coronavirus.