A company seeks US approval for an oral anti-Corona drug
The US drug company, Merck, has sought approval from the relevant authorities to obtain emergency use authorization for its anti-coronavirus drug, molnoiravir.
If approval is obtained, the new drug can reduce hospital admissions for people with “moderate to mild” cases of the disease.
The company said, on Monday, that it has applied to the US drug authorities and “regulatory agencies of the world” for emergency use authorization for its anti-coronavirus drug “molnoiravir”, according to the Associated Press.
According to the company, the drug, which is the first dedicated to treating corona orally, can reduce the percentage of critical cases of the disease, which require hospitalization, to 50 percent.
It said it was working “with regulatory agencies around the world to apply for emergency use or marketing authorization in the coming months.”
“The extraordinary impact of this pandemic requires that we act with unprecedented urgency,” Merck CEO and President Robert Davis said in the statement.
Wendy Holman, CEO of Merck partner Ridgeback Biotherapeutics, described the request as a “critical step towards making molonoperavir available to people who may benefit from an oral antiviral drug that can be taken at home soon after being diagnosed with Covid-19”.
In a late-stage clinical trial, Merck and Ridgeback evaluated data on about 770 patients — about half of whom received a five-day course of the drug, while the other half received a placebo.
Of the patients who received molnopiravir, 7.3 percent were hospitalized by day 29, compared to 14.1 percent of those taking a placebo, a relative risk reduction of 50 percent.
And the “Nature” scientific website said that the results of the data have not yet been reviewed by “arbitrators”, which is an approved medical method for evaluating scientific research, but “if the treatment is allowed by the regulatory authorities, it will be the first oral antiviral treatment for Covid-19.”
The site added that two Indian drug makers had independently sought to end testing of the drug in their country because they had not seen any “significant efficacy” of the experimental drug for those with “moderate injury”, although they plan to continue trials for people with mild injury.
But a company spokesperson noted that moderate cases of Covid-19 infections in India are known to be more severe than in the United States and involve hospitalization.
Information indicates that the drug withstands the virus’s mutants, including Delta, and that the drug has “good safety features.” But experts said it is not a miracle cure and should complement, not replace, vaccines.