“If Authorized, Molnupiravir Could be the First Oral Antiviral Medicine for COVID-19.”
Partnering pharmaceutical companies Merck and Ridgeback Biotherapeutics in a headline announcing promising results from an interim analysis of their COVID-19 pill.
oct 1, 2021
- On Friday, pharmaceutical companies Merck and Ridgeback Biotherapeutics announced interim results of their Phase 3 trial (final phase of clinical trials before companies can apply for FDA approval / authorization) on molnupiravir, an antiviral pill for COVID-19. This pill works to prevent the replication of the virus that causes COVID-19 in the body.
- Study? Interim analysis - evaluation of a current, ongoing trial's data - was completed on 775 non-hospitalized patients who had recently been infected with the virus that causes COVID-19, had "mild-to-moderate" symptoms, and had at least one risk factor (e.g., diabetes, heart disease). Earlier studies showed molnupiravir did not help hospitalized patients.
- Results? The interim analysis data found that the oral antiviral reduced participants' risk of death or hospitalization by about 50%. Through day 29 of the analysis, there were no deaths reported in patients who took molnupiravir, compared to eight deaths in the placebo group. Side effects were reported in both groups, but slightly more so in the group which received the placebo.
- The companies are applying for emergency use authorization (EUA) from the FDA "as soon as possible." With "the recommendation of an independent Data Monitoring Committee" and after consulting with the FDA, they also are halting further recruitment into these trials due to the strong positive results.
- What about variants? Merck reports: "... molnupiravir demonstrated consistent efficacy across viral variants Gamma, Delta, and Mu."
- How is the pill administered? Molnupiravir is to be taken over a five-day period early on in COVID-19 infections: four capsules, twice daily.
Why It Matters: If authorized, molnupiravir will be the first oral antiviral available to help treat COVID-19 and could make an impact on the fight against the pandemic worldwide. In April, Merck announced voluntary agreements with manufacturing facilities that will supply the antiviral to India and over 100 lower- and middle-income countries, pending authorization / approval. In June, the Biden administration made a deal with Merck to purchase 1.7 million treatment courses of the antiviral, pending authorization. In anticipation of the trial's results, Merck has been "producing molnupiravir at risk," expecting to have 10 million treatment courses available by the end of this year.
The Associated Press reports: All other therapies now authorized in the U.S. require an IV or injection. A pill taken at home, by contrast, would ease pressure on hospitals and could also help curb outbreaks in poorer and more remote corners of the world that don’t have access to the more expensive infusion therapies.
Click HERE for the announcement from Merck and Ridgeback, October 1, 2021.