U.K. approves 1st pill endorsed for treating those with COVID-19
Britain on Thursday approved the antiviral drug molnupiravir to treat the coronavirus, making it the first antiviral pill to be endorsed by a public health body for use in COVID-19 patients. Experts have said that the pill could offer fresh promise in combating the coronavirus, and its approval by the medicines regulator marks a major step.
The drug can be taken orally, which marks it apart from other treatments, such as remdesivir, which must be administered intravenously. The pill form makes it easier to treat the virus outside of a hospital, combating symptoms before they become severe.
A large clinical trial showed that molnupiravir halved the risk of hospitalization and death in high-risk COVID-19 patients who took the drug soon after infection, raising hopes internationally that the pill would be a new way to combat the virus.
Molnupiravir, developed by Merck and Ridgeback Biotherapeutics, has been submitted for emergency authorization to the U.S. Food and Drug Administration, which will host a public meeting to review the application at the end of the month. But even before the pill was approved by most regulators, wealthy nations have been scrambling to negotiate deals to buy the drug.Last month, Merck announced a licensing deal to allow molnupiravir to be made and sold cheaply in dozens of developing nations.
The decision Thursday to approve the drug for use in Britain was made after a “rigorous review” of its “safety, quality and effectiveness,” according to the statement from the watchdog, the Medicines and Healthcare Products Regulatory Agency.
Britain’s regulator authorized the drug for both vaccinated and unvaccinated people who have at least one factor that would put them at high risk for becoming severely ill from the virus. In the clinical trial, the most common risk factors were being older than 60 or having obesity or diabetes.
Dr. June Raine, the agency’s chief, said in a statement that scientists and clinicians were satisfied that the pill was “safe and effective for those at risk of developing severe COVID-19.”