Pharmaceutical giant Merck and its partner Ridgeback Biotherapeutics announced Friday that it plans to apply for emergency approval of its oral antiviral treatment for COVID-19 after the experimental drug showed “compelling results” in clinical trials.
The pill, called molnupiravir, cut the risk of hospitalization or death in patients with mild to moderate COVID-19 by about 50 percent in a late-stage trial, the companies said.
After discussions with both an independent data committee and staff from the US Food and Drug Administration, the companies decided to halt enrollment in its late-stage trial because of the positive results, Friday’s announcement said.
If the FDA grants Merck an emergency use authorization for the pill, it would be the first oral antiviral for COVID-19.
Merck revealed the early results of its late-stage trial in a press release, and it has yet to be published in a peer-reviewed medical journal.
Shares of the pharma giant surged nearly 5 percent to $78.70 per share in premarket trading on the news.
“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 Robert Davis said in a statement.
“With these compelling results, we are optimistic that molnupiravir can become an important medicine as part of the global effort to fight the pandemic,” he added.
The data revealed Friday was based on early results from 775 patients who had laboratory-confirmed symptomatic COVID-19 and were enrolled in the phase three trial by early August.
All participants were unvaccinated and had at least one underlying factor that put them at high risk of developing a more severe case of the disease.
Participants were randomly chosen to receive either molnupiravir or a placebo within five days of the start of their symptoms.
The interim analysis of the data found that 7.3 percent of patients treated with the pill were hospitalized within 29 days after the trial began, compared with 14.1 percent of patients who received a placebo and were either hospitalized or dead by that time.
Of the patients who received the pill, none died. Among the placebo recipients, eight patients died.
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