Drugmaker Merck said Friday that it will seek U.S. Food and Drug Administration approval for a drug the company says reduces the chance of death by about half for some COVID patients.
Along with partner company Ridgeback Biotherapeutics, Merck will apply for an emergency authorization for the drug, molnupiravir, a pill that is taken by mouth and works by inhibiting the replication of the coronavirus in the patient’s body.
“Merck plans to seek emergency use authorization in the U.S. as soon as possible and to submit applications to regulatory agencies worldwide,” Merck said in a press release.
The pill reduces the chance of hospitalization or death by about 50% for patients with mild or moderate cases of COVID-19, according to a phase three trial of the medicine. Among 775 trial participants diagnosed with the virus, 14.1% who were treated with just a placebo were hospitalized or died within 29 days. Only 7.3% of those who were treated with molnupiravir were hospitalized within 29 days, roughly half as many.
Over the 29 days of the trial, no patients who received the new drug died, while eight patients who received the placebo died.
“This is a phenomenal result. This is a profound game-changer that we have an oral pill that had this kind of effect on patients who are already symptomatic,” said former FDA commissioner Scott Gottlieb on CNBC.
The trial found that the drug was effective at treating all variants of COVID-19, including the delta variant.
If approved, the pill would be the first Covid treatment able to be taken by mouth. All currently approved treatments must be administered intravenously or through an injection.
All the trial participants were unvaccinated and had at least one underlying condition putting them at risk of a severe case, such as obesity, heart disease, diabetes, or being over age 60. The underlying conditions did not affect how effective molnupiravir was at treating patients, the trial found.
Phase three of the trial was conducted across various countries including the U.S., Canada, the United Kingdom, Russia, South Africa, Egypt, Israel, Japan, Mexico, several Central American and South American countries, and several countries in mainland Europe.
“More tools and treatments are urgently needed to fight the COVID-19 pandemic, which has become a leading cause of death and continues to profoundly affect patients, families, and societies and strain health care systems all around the world. 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 Merck’s chief executive officer and president Robert Davis.
Davis added that the company will now “do everything we can to bring molnupiravir to patients as quickly as possible.”
Last month, the Biden administration moved to ration a different COVID-19 treatment, monoclonal antibodies, arguing that the move was necessary to prevent shortages of the treatment.
“HHS will determine the amount of product each state and territory receives on a weekly basis. State and territorial health departments will subsequently identify sites that will receive product and how much,” a Department of Health and Human Services representative said. “This system will help maintain equitable distribution, both geographically and temporally, across the country — providing states and territories with consistent, fairly distributed supply over the coming weeks.”
The move prompted pushback from Texas Governor Greg Abbott, who said his state has obtained its own supply of monoclonal antibodies, bypassing the Biden administration’s attempts to control the supply.