Britain’s medicines regulator has given a green light on Thursday to an antiviral COVID-19 pill jointly developed by U.S.-based Merck and partner Ridgeback Biotherapeutics.
The drug, known as molnupiravir, has been recommended by Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) to be used during the early stages of infection, within five days of the onset of symptoms, according to clinical data, a Nov. 4 government statement shows.
Thursday’s approval marks Britain as the first nation worldwide to authorize the oral antiviral COVID-19 treatment. The pill is meant to combat cases of mild or moderate COVID-19, the disease caused by the CCP (Chinese Communist Party) virus.
Merck’s molnupiravir can cut the risk of hospitalization or death in half for adults who were deemed at risk but not hospitalized, according to a summary the company released last month.
The drug, to be branded Lagevrio in Britain, is designed to introduce errors into the genetic code of the virus that causes COVID-19 and is taken twice a day for five days.
“Lagevrio is another therapeutic to add to our armory against COVID-19,” MHRA’s chief executive, Dr. June Raine, said on Thursday.
“It is also the world’s first approved antiviral for this disease that can be taken by mouth rather than administered intravenously,” she added. “This is important because it means it can be administered outside of a hospital setting, before COVID-19 has progressed to a severe stage.”
The British government and the country’s National Health Service (NHS) will confirm how the treatment will be deployed to patients in “due course.”
“We are working at pace across the government and with the NHS to set out plans to deploy molnupiravir to patients through a national study as soon as possible,” UK health minister Sajid Javid said on Thursday.
Last month, Merck and its partner announced that they filed an emergency use authorization application with the U.S. Food and Drug Administration (FDA). U.S. advisers will meet this month to vote on whether molnupiravir should be authorized.
Merck’s results have been jointly touted by the companies and a number of experts, including former FDA Commissioner Scott Gottlieb.
“This is a phenomenal result. I mean, this is a profound game-changer, to have an oral pill that had this kind of effect, this magnitude of effect in patients who are at high risk who are already symptomatic,” Gottlieb said on CNBC’s “Squawk Box.”
Other researchers and experts have expressed concerns about how the pill attacks the virus, saying that the method carries risk potential because “the same mutagenic activity that impacts viral replication has the potential for incorporation and mutagenesis of host DNA,” which could contribute to the development of cancer or cause birth defects in an unborn baby. That’s what happened during testing of NHC, the compound molnupiravir creates.
“There is a concern that this will cause long-term mutation effects, even cancer,” Dr. Shuntai Zhou, a scientist at the Swanstrom Lab at the University of North Carolina, told Barron’s.
Dr. Michael Carome, director of Public Citizen’s Health Research Group, told The Epoch Times that the concern is theoretical for now and that it’s likely that signaling of rare adverse events would only be possible with long-term trials because premarket trials typically only involve several thousand participants.
Zachary Stieber and Reuters contributed to this report.
