Officials with the drugmaker Merck said Friday that the company’s experimental oral drug to treat COVID-19, molnupiravir, reduced the risk of hospitalization or death by about half, and that they plan to submit an application for emergency use authorization of the drug “as soon as possible.”
If cleared, the drug would be the first pill shown to treat COVID-19, a potentially major advance in efforts to fight the pandemic. All COVID-19 therapies now authorized in the U.S. require an IV or injection.
“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,” Merck’s CEO and president, Robert M. Davis, said in a statement. He added that Merck “will continue to work with regulatory agencies on our applications and do everything we can to bring molnupiravir to patients as quickly as possible.”
Officials with the company and its partner, Ridgeback Biotherapeutics, said early results of their Phase 3 trial showed molnupiravir reduced the risk of hospitalization or death for people who have underlying conditions which can exacerbate a COVID-19 infection, such as obesity, diabetes or heart disease. The results also showed the drug was effective against the gamma, delta and mu variants of the virus.
The study tracked 775 adults who had mild-to-moderate COVID-19 infections and who began treatment with molnupiravir within five days of experiencing symptoms. Merck said that through the 29th day of treatment, about 7% of patients who received the drug were hospitalized or died due to COVID-19, compared to 14% of patients who received a placebo. No deaths were reported in people who received molnupiravir while eight deaths were reported in patients who got placebos, according to Merck.
The results were released by the company and have not been peer reviewed. Merck said it plans to present them at a future medical meeting.
Side effects seen in patients who received molnupiravir were comparable to those seen in patients who received a placebo, although Merck did not provide specifics about the side effects seen.
An independent group of medical experts monitoring the trial recommended stopping it early because the interim results were so strong. Merck has planned to enroll 1,500 patients in its late-stage trial.
The company expects to produce 10 million courses of molnupiravir by the end of 2021. It also has a contract with the U.S. government to supply 1.7 million courses of the drug at a price of $700 each, according to Reuters.
Several other companies, including Pfizer and Roche, are studying similar drugs that could report results in the coming weeks and months.
The Associated Press contributed to this report.
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