JUST IN: Drugmaker Merck to Seek FDA Approval for Covid Pill it Claims Cuts Risk of Death by Half

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Drugmaker Merck announced on Friday that it would soon seek approval from the U.S. Food and Drug Administration for a pill the company claims cuts the risk of hospitalization or death from Covid-19 by half.

If approved by health officials, the drug, known as molnupiravir, would become the first oral medicine used to treat the virus, as all current authorized therapies require wither an IV or injection.

Merck and its partner Ridgeback Biotherapeutics said early results in a clinical trial showed that patients who received the drug within five days of their Covid-19 symptoms had roughly half the rate of hospitalization and death as patients who received a placebo pill.

The study examined 775 adults considered higher risk for severe disease that had mild-to-moderate coronavirus symptoms.

“At the interim analysis, molnupiravir reduced the risk of hospitalization or death by approximately 50%,” Merck said in a news release. “7.3% of patients who received molnupiravir were either hospitalized or died through Day 29 following randomization (28/385), compared with 14.1% of placebo treated patients (53,377). Through Day 29, no deaths were reported in patients who received molnupiravir, as compared to 8 deaths in patients who received placebo.”

The results were released by Merck but have not yet been reviewed by outside experts in the field, which is the typical procedure.

“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,” said Robert M. Davis, chief executive officer and president of Merck.

“With these compelling results, we are optimistic that molnupiravir can become an important medicine as part of the global effort to fight the pandemic and will add to Merck’s unique legacy of bringing forward breakthroughs in infectious diseases when they are needed most. Consistent with Merck’s unwavering commitment to save and improve lives, 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 described the medication as an “investigational, orally administered form of a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2,” which is the causative agent of Covid-19.

The press release added that “Molnupiravir has been shown to be active in several preclinical models of SARS-CoV-2, including for prophylaxis, treatment, and prevention of transmission,” noting that “pre-clinical and clinical data have shown molnupiravir to be active against the most common SARS-CoV-2 variants.”