Merck Asks FDA Emergency Authorisation for Experimental COVID-19 Pill
13:40 GMT 11.10.2021 (Updated: 14:01 GMT 11.10.2021)
WASHINGTON (Sputnik) - American pharmaceutical company Merck & Co said on 11 October that it has requested emergency approval from the US drug regulator for its antiviral COVID-19 treatment.
On 1 October, the pharmaceutical giant announced a successful trial of molnupiravir, which reduces the risk of hospitalisation and death from COVID-19 by 50%.
"Merck has submitted an Emergency Use Authorisation (EUA) application to the US Food and Drug Administration (FDA) for molnupiravir, an investigational oral antiviral medicine, for the treatment of mild-to-moderate COVID-19 in adults who are at risk for progressive to severe COVID-19 and/or hospitalisation", the company said.
If approved, the pill, which Merck developed with Ridgeback Biotherapeutics, would be the first oral COVID-19 drug approved by the FDA.
"At the interim analysis, molnupiravir reduced the risk of hospitalisation or death by approximately 50%", the statement read.
An interim analysis of a phase 3 study found that 7.3% of patients treated with molnupiravir were hospitalised within 29 days. Of the patients who received a placebo, 14.1% were hospitalised or had died by day 29. No deaths were reported among patients who were given molnupiravir within the 29-day period, while eight deaths were reported in placebo-treated patients.
All 775 trial participants had laboratory-confirmed symptoms of COVID-19, and molnupiravir or a placebo were randomly administered within five days of symptoms, the statement said.
Adverse events were comparable in the molnupiravir and placebo groups, with around 10% reporting adverse events. Just 1.3% of the molnupiravir group discontinued therapy due to an adverse event — less than the 3.4% of the placebo group did so.
Participants were unvaccinated and had at least one underlying factor that put them at greater risk of developing a more severe case of the virus. The most common risk factors included obesity, being over 60 years of age, diabetes, or heart disease.
Molnupiravir's efficacy was not affected by the timing of symptom onset or patients' underlying risk factors, the study showed. It also proved to be consistently effective in treating all COVID-19 variants, including the widely dominant and highly transmissible Delta strain.
The trial was conducted at more than 170 locations, in countries including the United States, Canada, the United Kingdom, Brazil, Italy, Japan, South Africa, Spain, Ukraine, and Guatemala.