(Washington) A group of independent American scientists spoke out in support of Merkin’s anti-Covit-19 pill on Tuesday, which could treat some at-risk adults, paving the way for its recognition in the United States in the coming days.
This drug, Molnupravir, has already been approved in Great Britain in early November, where it is marketed under the name Logevrio.
Antiviral therapies are eagerly awaited because they can reduce the severe form of COVID-19 by taking home pills as soon as symptoms appear in the event of an infection.
The U.S. Drug Enforcement Agency (FDA), which convened Tuesday’s meeting, will make the final decision on granting the drug emergency approval after an uncontested vote.
He suggested that molnupravir may be prescribed to people with mild and moderate cases of the disease and to those who are hospitalized or at high risk of developing a serious illness that can lead to death (obesity, old age …).
David Hardy, a member of the committee that spoke for his emergency recognition, underlined that this was the first time the population had access to out-of-hospital treatment.
An expert vote at the end of the debate, which aired live one day, voted 13 in favor and 10 against. Many called the decision “difficult.”
They were particularly concerned about the lower efficacy than expected at the beginning of treatment.
According to data released on Friday, the full results of a clinical trial of 1,400 participants showed a 30% reduction in hospital admissions and mortality among at-risk patients. However, the initial results, which took into account only a fraction of the test participants, initially put the figure at 50%.
There is a significant difference between the recipients of the placebo in the second half of the trial due to the lower number of hospital admissions, which is not clearly explained by the company.
Not for pregnant women?
Merck, also known as MSD outside the United States, told the panel in a presentation that he did not recommend the use of molnupravir in pregnant women.
On Tuesday, several experts in the group said pregnant women should avoid this treatment or at least support themselves if they have synthetic antibodies.
In documents released Friday before the meeting, the FDA noted some adverse effects on fetal development during animal testing. Observations made on pregnant mice and rabbits show that some litters were more defective than the control groups.
Children will not be affected by Tuesday’s results, and pediatric trials will not be considered until the results of current experiments on young mice are available.
The first symptoms are treated within five days, twice a day for five days.
Molnupravir works by introducing a mutation into the virus, which stops its response.
Be effective against variations
Experts on Tuesday raised concerns that the treatment could create new, unwanted mutations in the virus due to its technology.
“Risk of mutation effects […] Not firmly established or categorized, ”said committee member Shankar Swaminathan, who voted against the recommendation.
However, Merck’s biochemist Daria Hasuda told AFP that “not treating patients and allowing the virus to develop naturally (which) is more dangerous than the ability of the molecule to lead to evolution”.
This mechanism also has an advantage over newer variants. Unlike other treatments such as synthetic antibodies or vaccines, antivirals do not target the spike protein, which is used by the virus to enter cells. However, the Omigron variant contains precisely several mutations in this protein, which raises concerns among experts about the effectiveness of the solutions.
Instead, Merck expects Molnupravir to have “similar action against any new variant,” Taria Hasuda said during a meeting on Tuesday.
Pfizer is also developing an antiviral treatment, branded as Paxlovit, which works differently by blocking the enzyme needed to copy the virus.
The United States has already ordered 3.1 million treatments from Merck and 10 million from Pfizer.