Merck requests US approval for an anti-Corona drug

 The US drug giant Merck said on Monday that it has applied to the US drug authorities and "regulatory agencies in the world" for emergency use authorization for its anti-coronavirus drug "molnoiravir".

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 submit applications 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 received a placebo.

Of the patients who received molonopiravir, 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.

The science website Nature said that the data results have not yet been reviewed by "referees" and are an approved medical method for evaluating scientific research, but "if the treatment is allowed by less regulators, it will be the first oral antiviral treatment for COVID-19."

The site added that two Indian drug makers independently sought to end testing the drug in their country because they "did not see 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.

Merck said in the statement that it expects to produce 10 million treatment cycles by the end of 2021, with more cycles expected in 2022.

The United States has purchased 1.7 million cycles of molnopiravir if approved, with the option to buy more, and the global health agency Unitaid said it is working with a partnership called ACT-Accelerator to secure the drug to low- and middle-income countries.

Merck said it "plans to implement a tiered pricing approach based on country income criteria defined by the World Bank to reflect the relative ability of countries to finance their health response to the pandemic."

The company said it has also signed, pending permits, voluntary non-exclusive licensing agreements for molnopiravir with Indian drug manufacturers to accelerate access to the drug in more than 100 low- and middle-income countries.