Merck to seek emergency US approval of oral COVID treatment


Pharmaceutical big Merck and its accomplice Ridgeback Biotherapeutics introduced Friday that it plans to apply for emergency approval of its oral antiviral treatment for COVID-19 after the experimental drug confirmed “compelling results” in scientific trials.

The capsule, known as molnupiravir, reduce the chance of hospitalization or loss of life in sufferers with gentle to average COVID-19 by about 50 p.c in a late-stage trial, the businesses mentioned.

After discussions with each an unbiased information committee and employees from the US Food and Drug Administration, the businesses determined to halt enrollment in its late-stage trial as a result of of the constructive outcomes, Friday’s announcement mentioned.

If the FDA grants Merck an emergency use authorization for the capsule, it might be the primary oral antiviral for COVID-19.

Merck revealed the early outcomes of its late-stage trial in a press launch, and it has but to be revealed in a peer-reviewed medical journal.

Molnupiravir would change into the primary oral antiviral for COVID-19 if accredited by the US Food and Drug Administration.

Shares of the pharma big surged practically 5 p.c to $78.70 per share in premarket buying and selling on the information.

“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 mentioned in an announcement.

“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 information revealed Friday was based mostly on early outcomes from 775 sufferers who had laboratory-confirmed symptomatic COVID-19 and had been enrolled within the part three trial by early August.

Merck’s CEO Robert Davis believes the capsule may “become an important medicine” to battle the COVID-19 pandemic.

All individuals had been unvaccinated and had no less than one underlying issue that put them at excessive danger of growing a extra extreme case of the illness.

Participants had been randomly chosen to obtain both molnupiravir or a placebo inside 5 days of the beginning of their signs.

The interim evaluation of the info discovered that 7.3 p.c of sufferers handled with the capsule had been hospitalized inside 29 days after the trial started, in contrast with 14.1 p.c of sufferers who acquired a placebo and had been both hospitalized or lifeless by that point.

Of the sufferers who acquired the capsule, none died. Among the placebo recipients, eight sufferers died.