Merck Seeks Emergency Use Authorization for its New Covid Oral Drug

Oct 1, 2021 By MarketDepth

Biotechnology Headlines Healthcare Investing What's Hot


Merck (NYSE: MRK) and Ridgeback Biotherapeutics announced Friday that they have created an oral drug, molnupiravir, that reduces the risk of hospitalization or death by approxiametly 50% in people with mild or moderate Covid-19 cases. The companies plan to request emergency use authorization from the US Food and Drug Administration, after the drug showed “compelling results” throughout clinical trials.

“At the interim analysis, molnupiravir reduced the risk of hospitalization or death by approximately 50%. 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.”

Merck said in a news release

Molnupiravir would be the first oral drug to directly take on Covid-19. Experts have said that such a drug may be our best chance to defeat the widespread disease. Patients could use the drug shortly after being diagnosed to prevent symptoms from escalating.

Phase 3 Results

During a phase 3 study, 7.3% of patients that received the drug were hospitalized within 29 days and had no reported deaths. Meanwhile, amid those patients that were given a placebo, 14.1% were hospitalized or died by day 29. 

Drug Administered After Five Days

All trial participants had been tested for Covid-19 and were administered molnupiravir or the placebo within five days of arising symptoms. Furthermore, all clinical trial patients were unvaccinated and had some sort of underlying factor which increased their risk. The phase 3 trial took place in various countries such as the U.S., Brazil, Italy, Japan, South Africa, Taiwan and Guatemala.