An oral antiviral treatment for COVID-19 in adults named molnupiravir received approval from regulators in Britain Thursday, making it the first such medication authorized for use against the virus by a public health body.
Merck, the U.S. company that manufactured the drug, announced Thursday that applications for its use also remain under review by the U.S.
Food and Drug Administration and the European Medicines Agency. The company is also submitting applications to other regulatory agencies worldwide.
In the U.K., the drug has been authorized for treatment of mild-to-moderate COVID-19 in adults with a positive SARS-CoV-2 diagnostic test who at least 60 years old or have at least one risk factor for developing severe illness. It will be trademarked under the name Lagevrio.
Experts have said that if widely authorized, the medicine could have huge potential to help fight the coronavirus pandemic, according to The Washington Post.
Since pills are easier to take, store and distribute than vaccines – which have to be kept at specific temperatures and often require more than one dose with some time in between – they could help mitigate COVID-19 outbreaks in lower to middle income countries. Some of these countries have limited access to vaccine supplies and infrastructure issues that makes it difficult to get vaccines to people.
“The first global authorization of molnupiravir is a major achievement in Merck’s singular legacy of bringing forward breakthrough medicines and vaccines to address the world’s greatest health challenges. In pursuit of Merck’s unwavering mission to save and improve lives, we will continue to move with both rigor and urgency to bring molnupiravir to patients around the world as quickly as possible,” said Robert M. Davis, chief executive officer and president of Merck.
The company describes molnupiravir as “an investigational, orally administered form of a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2, the causative agent of COVID-19.”
According to Merck, authorization of the drug is based on positive results from a planned interim analysis from a clinical trial. This trial evaluated molnupiravir 800 mg twice-daily in non-hospitalized, unvaccinated adult patients with laboratory-confirmed mild-to-moderate COVID-19, symptom onset within five days of study and at least one risk factor for severe illness.
In addition to being easier to distribute and use than preventative vaccines, these pills are also easier to use than infused or injected monoclonal antibody treatments for people already battling COVID-19, said The Washington Post.
“Virologists have said they are hopeful that as well as limiting the risk of developing severe illness, the treatment could help reduce transmission of the virus too,” according to the outlet.
Molnupiravir was invented at Drug Innovations at Emory (DRIVE), LLC, a not-for-profit biotechnology company owned by Emory University.
Some research funding from the U.S. Department of Defense and the National Institutes of Health.
By the end of 2021, Merck expects to produce 10 million courses of molnupiravir treatment, followed by another 20 million in 2022.
As of Thursday, the U.S. government had already entered into a procurement contract with the company to purchase approximately 1.7 million courses of molnupiravir upon EUA or approval from the U.S. FDA. Other purchase agreements across the globe include a deal with the U.K. to buy 480,000 courses of therapy.
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