A recent study found that an experimental oral antiviral medicine by Merck effectively treats COVID-19 and all of its variants. The jury is still out on whether Merck's antiviral drug is as effective as the vaccine.
On Oct. 1, Merck and Ridgeback Biotherapeutics announced that lab studies show that its oral antiviral drug molnupiravir significantly reduced the risk of hospitalization or death from COVID-19 by about 50 percent.
In a phase 3 study of 775 people who had mild-to-moderate COVID symptoms, none of those treated with molnupiravir died within the study’s 29-day period. There were eight deaths in the patients who received a placebo.
The study found that 7.3 percent of patients treated with molnupiravir were hospitalized, while 14.1 percent of those who received the placebo were hospitalized or died. More patients in the placebo group (less than 3.4 percent) had to discontinue the treatment due to adverse events than those who received molnupiravir (about 1.3 percent).
Merck's antiviral drug was tested on unvaccinated patients.
Patients who participated in the study were unvaccinated and had at least one risk factor like diabetes, obesity, heart disease, or were over age 60. The study found that a patient’s underlying health issues and when their symptoms started didn’t affect the drug’s efficacy.
The phase 3 trial was conducted at over 170 sites in various countries, including the U.S., United Kingdom, Brazil, Egypt, Italy, Japan, Mexico, and South Africa.
On the recommendation of the independent Data Monitoring Committee and in consultation with the FDA, the study stopped early due to its positive results, company officials said.
“With these compelling results, we are optimistic that molnupiravir can become an important medicine as part of the global effort to fight the pandemic,” said Robert M. Davis, Merck's CEO and president. “We will continue to work with regulatory agencies on our applications and do everything we can to bring molnupiravir to patients as quickly as possible.”
Merck will seek emergency use authorization for the drug.
Merck plans to seek emergency use authorization for the antiviral drug “as soon as possible.” Under an emergency use authorization, the FDA allows the use of unapproved medical drugs during public health emergencies, like the COVID-19 pandemic. The current COVID vaccines from Moderna and Johnson & Johnson have emergency use authorization. Pfizer’s vaccine received full FDA approval in August.
“We are very encouraged by the results from the interim analysis and hope molnupiravir, if authorized for use, can make a profound impact in controlling the pandemic,” said Wendy Holman, the CEO of Ridgeback Biotherapeutics.
Merck plans to produce 10 million courses by the end of this year.
Merck expects to produce 10 million courses of treatment by the end of 2021, with more doses expected to be produced in 2022. Earlier this year, the company agreed to supply the U.S. government with about 1.7 million doses of molnupiravir. It also has agreements with other governments around the world.
A separate study is testing Merck's drug for preventing COVID-19.
A separate phase 3 study is evaluating how effective Merck’s molnupiravir is in preventing COVID-19.