Merck to seek emergency US approval of oral COVID treatment

[mystery-ak]

 Merck to seek emergency US approval of oral COVID treatment
By Will Feuer   
October 1, 2021 7:15am

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.

more
https://nypost.com/2021/10/01/merck-to-seek-emergency-us-approval-of-oral-covid-treatment/

[Right_in_Virginia]

Merck says experimental pill cuts worst effects of COVID-19
Associated Press, Oct 1, 2021

WASHINGTON (AP) — Drugmaker Merck said Friday that its experimental COVID-19 pill reduced hospitalizations and deaths by half in people recently infected with the coronavirus and that it would soon ask health officials in the U.S. and around the world to authorize its use.

If cleared, the drug would be the first pill shown to treat COVID-19, a potentially major step forward in global efforts to control the pandemic. All COVID-19 therapies now authorized in the U.S. require an IV or injection.

A pill that could be taken at home, by contrast, could keep many patients out of the hospital, easing the workload on strained health care professionals. It could also help curb outbreaks in lower-income countries that don’t have access to the more expensive infusion therapies.

Merck and its partner Ridgeback Biotherapeutics said early results showed patients who received the drug, called molnupiravir, within five days of COVID-19 symptoms had about half the rate of hospitalization and death as patients who received a dummy pill. The study tracked 775 adults with mild-to-moderate COVID-19 who were considered higher risk for severe disease due to health problems such as obesity, diabetes or heart disease. The results have not been peer reviewed by outside experts, the usual procedure for vetting new medical research.


More:
https://apnews.com/article/merck-says-experimental-covid-pill-cuts-worst-effects-a9a2245fdcee324f6bbd776a0fffcc60

[Right_in_Virginia]

Rumor has it Fauci is on life support.   

[PeteS in CA]

This press release from this AM (with some key points bolded by me):

Merck and Ridgeback’s Investigational Oral Antiviral Molnupiravir Reduced the Risk of Hospitalization or Death by Approximately 50 Percent Compared to Placebo for Patients with Mild or Moderate COVID-19 in Positive Interim Analysis of Phase 3 Study

https://www.merck.com/news/merck-and-ridgebacks-investigational-oral-antiviral-molnupiravir-reduced-the-risk-of-hospitalization-or-death-by-approximately-50-percent-compared-to-placebo-for-patients-with-mild-or-moderat/

KENILWORTH, N.J. & MIAMI--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today announced that molnupiravir (MK-4482, EIDD-2801), an investigational oral antiviral medicine, significantly reduced the risk of hospitalization or death at a planned interim analysis of the Phase 3 MOVe-OUT trial in at risk, non-hospitalized adult patients with mild-to-moderate COVID-19. 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); p=0.0012. Through Day 29, no deaths were reported in patients who received molnupiravir, as compared to 8 deaths in patients who received placebo. At the recommendation of an independent Data Monitoring Committee and in consultation with the U.S. Food and Drug Administration (FDA), recruitment into the study is being stopped early due to these positive results. Merck plans to submit an application for Emergency Use Authorization (EUA) to the U.S. FDA as soon as possible based on these findings and plans to submit marketing applications to other regulatory bodies worldwide.