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How does Merck's Molnupiravir differ from Ivermectin?

How does Merck's Molnupiravir differ from Ivermectin?

This article was published on
October 5, 2021

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Evidence of the Molnupiravir's safety and effectiveness was strong enough for the independent board of medical experts monitoring the study to recommend that the clinical trials be stopped early, before enrolling and studying all of the 1,550 intended participants, enabling the drug to proceed with regulatory approval processes. In contrast, there is currently no evidence that Ivermectin is effective against COVID-19, including a large study showing no benefit compared to a placebo and another flawed study being withdrawn from a pre-print platform.

Evidence of the Molnupiravir's safety and effectiveness was strong enough for the independent board of medical experts monitoring the study to recommend that the clinical trials be stopped early, before enrolling and studying all of the 1,550 intended participants, enabling the drug to proceed with regulatory approval processes. In contrast, there is currently no evidence that Ivermectin is effective against COVID-19, including a large study showing no benefit compared to a placebo and another flawed study being withdrawn from a pre-print platform.

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What our experts say

Molnupiravir is an experimental antiviral drug, originally developed by the pharmaceutical company Merck for the treatment of influenza (flu). The medication, given in the form of an oral pill, interferes with how viruses copy their genetic material, ribonucleic acid (RNA). This prevents the virus from spreading in our bodies and can help treat patients at risk for severe cases of viral disease.

On October 1, 2021, Merck announced that it will be pursuing Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) and other regulatory agencies worldwide due to promising results from clinical trials. The Phase 3 trial's interim analysis showed that Molnupiravir reduced hospitalizations and death by about 50% compared to a placebo. The analysis looked at 775 adults with mild-to-moderate COVID-19 who were at risk of severe disease due to underlying health conditions, and were from North America, Latin America, Europe, and Africa. Of the participants, 7.3% of patients who received Molnupiravir were hospitalized through day 29 of the study, whereas 14.1% of patients who received a placebo were hospitalized or died. 

Evidence of the Molnupiravir's safety and effectiveness was strong enough for the independent board of medical experts monitoring the study to recommend that the clinical trials be stopped early, before enrolling and studying all of the 1,550 intended participants, enabling the drug to proceed with regulatory approval processes.

In contrast, there is currently no evidence that Ivermectin is effective against COVID-19, including a large study showing no benefit compared to a placebo and another flawed study being withdrawn from a pre-print platform. Ivermectin is an anti-parasitic drug that is used to treat infections caused by roundworms, threadworms, and other parasites. The U.S. FDA has warned against self-administering Ivermectin for COVID-19, particularly from veterinary sources intended for animal use rather than human use, as this decreases the supply of the drug for necessary uses and can pose safety risks if given incorrectly.

Health experts recommend first trying to prevent COVID-19 through precautionary measures like vaccination, hand washing, mask wearing, and physical distancing. If diagnosed with COVID-19, health experts recommend self-isolation to prevent infecting others and consulting healthcare professionals for treatment as necessary using authorized medications that have been proven to be safe and effective.

Molnupiravir is an experimental antiviral drug, originally developed by the pharmaceutical company Merck for the treatment of influenza (flu). The medication, given in the form of an oral pill, interferes with how viruses copy their genetic material, ribonucleic acid (RNA). This prevents the virus from spreading in our bodies and can help treat patients at risk for severe cases of viral disease.

On October 1, 2021, Merck announced that it will be pursuing Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) and other regulatory agencies worldwide due to promising results from clinical trials. The Phase 3 trial's interim analysis showed that Molnupiravir reduced hospitalizations and death by about 50% compared to a placebo. The analysis looked at 775 adults with mild-to-moderate COVID-19 who were at risk of severe disease due to underlying health conditions, and were from North America, Latin America, Europe, and Africa. Of the participants, 7.3% of patients who received Molnupiravir were hospitalized through day 29 of the study, whereas 14.1% of patients who received a placebo were hospitalized or died. 

Evidence of the Molnupiravir's safety and effectiveness was strong enough for the independent board of medical experts monitoring the study to recommend that the clinical trials be stopped early, before enrolling and studying all of the 1,550 intended participants, enabling the drug to proceed with regulatory approval processes.

In contrast, there is currently no evidence that Ivermectin is effective against COVID-19, including a large study showing no benefit compared to a placebo and another flawed study being withdrawn from a pre-print platform. Ivermectin is an anti-parasitic drug that is used to treat infections caused by roundworms, threadworms, and other parasites. The U.S. FDA has warned against self-administering Ivermectin for COVID-19, particularly from veterinary sources intended for animal use rather than human use, as this decreases the supply of the drug for necessary uses and can pose safety risks if given incorrectly.

Health experts recommend first trying to prevent COVID-19 through precautionary measures like vaccination, hand washing, mask wearing, and physical distancing. If diagnosed with COVID-19, health experts recommend self-isolation to prevent infecting others and consulting healthcare professionals for treatment as necessary using authorized medications that have been proven to be safe and effective.

Context and background

Molnupiravir is a drug named after Mjölnir, the hammer of the god of thunder in Norse mythology known as Thor. There is growing interest in Molnupiravir for treatment of COVID-19, given the promising interim results from recent clinical trials. Molnupiravir showed less effective results in an earlier study of patients with advanced cases of COVID-19 who were already hospitalized, so a more likely application is in non-hospitalized patients with earlier stages of COVID-19. Multiple governments have been negotiating to purchase this drug from Merck, ranging from the United States to Australia to Thailand. On October 5, 2021, the European Medicines Agency (EMA) announced that it will consider launching a rolling review of Molnupiravir for regulatory approval in the European Union (EU).

If authorized, Molnupiravir has the potential to become one of the first antiviral drugs for COVID-19 that can be given orally. Remdesivir, an antiviral drug currently approved by the U.S. FDA for treatment of COVID-19, needs to be given by intravenous injections (IV) over multiple days. Treatments that can be taken as a pill at home may help reduce strain on healthcare facilities and reduce the risk of infecting healthcare workers. Other drugs that can be given orally are currently being studied for COVID-19.

There are significant benefits to having improved treatment options for COVID-19, including potential lives saved. Beyond the benefits, it is important to recognize that many COVID-19 treatments - existing and in development - are currently more expensive and less available compared to preventative measures such as vaccination. For example, as of October 2021, Molnupiravir is estimated to cost $700 per patient and there is a limited capacity for supply. In contrast, vaccines vary in cost but even the more expensive options are several times cheaper than Molnupiravir and billions of vaccine doses have been produced. With vaccines as well as treatment drugs, there remain major inequities in availability around the world. 

Molnupiravir is a drug named after Mjölnir, the hammer of the god of thunder in Norse mythology known as Thor. There is growing interest in Molnupiravir for treatment of COVID-19, given the promising interim results from recent clinical trials. Molnupiravir showed less effective results in an earlier study of patients with advanced cases of COVID-19 who were already hospitalized, so a more likely application is in non-hospitalized patients with earlier stages of COVID-19. Multiple governments have been negotiating to purchase this drug from Merck, ranging from the United States to Australia to Thailand. On October 5, 2021, the European Medicines Agency (EMA) announced that it will consider launching a rolling review of Molnupiravir for regulatory approval in the European Union (EU).

If authorized, Molnupiravir has the potential to become one of the first antiviral drugs for COVID-19 that can be given orally. Remdesivir, an antiviral drug currently approved by the U.S. FDA for treatment of COVID-19, needs to be given by intravenous injections (IV) over multiple days. Treatments that can be taken as a pill at home may help reduce strain on healthcare facilities and reduce the risk of infecting healthcare workers. Other drugs that can be given orally are currently being studied for COVID-19.

There are significant benefits to having improved treatment options for COVID-19, including potential lives saved. Beyond the benefits, it is important to recognize that many COVID-19 treatments - existing and in development - are currently more expensive and less available compared to preventative measures such as vaccination. For example, as of October 2021, Molnupiravir is estimated to cost $700 per patient and there is a limited capacity for supply. In contrast, vaccines vary in cost but even the more expensive options are several times cheaper than Molnupiravir and billions of vaccine doses have been produced. With vaccines as well as treatment drugs, there remain major inequities in availability around the world. 

Resources

  1. 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 (Merck)
  2. Efficacy and Safety of Molnupiravir (MK-4482) in Non-Hospitalized Adult Participants With COVID-19 (MK-4482-002) (ClinicalTrials.gov)
  3. Why You Should Not Use Ivermectin to Treat or Prevent COVID-19 (U.S. Food and Drug Administration)
  4. Flawed ivermectin preprint highlights challenges of COVID drug studies (Nature)
  5. Early Treatment of COVID-19 with Repurposed Therapies: The TOGETHER Adaptive Platform Trial (McMaster University and Pontifical Catholic University of Minas Gerais)
  6. Is ivermectin a proven treatment for COVID-19? (Health-Desk.org)
  7. Coronavirus (COVID-19) | Drugs (U.S. Food and Drug Administration)
  8. Merck says COVID-19 pill cuts risk of death, hospitalization (AP News)
  9. Merck pill seen as 'huge advance,' raises hope of preventing COVID-19 deaths (Reuters)
  10. Australia to buy Merck's COVID-19 pill, Victoria cases hit record (Reuters)
  11. Thailand joins Asian nations in rush to buy Merck's COVID-19 pill (Reuters)
  12. EMA to consider rolling review for Merck's molnupiravir in coming days (Reuters)
  13. Covid antiviral pill can halve risk of hospitalisation (British Broadcasting Corporation)
  14. What we know — and don’t know — about Merck’s new Covid-19 pill (STAT News)
  15. What Merck’s new COVID pill can actually do (Popular Science)
  16. Why Merck’s Covid-19 pill molnupiravir could be so important (Vox)
  1. 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 (Merck)
  2. Efficacy and Safety of Molnupiravir (MK-4482) in Non-Hospitalized Adult Participants With COVID-19 (MK-4482-002) (ClinicalTrials.gov)
  3. Why You Should Not Use Ivermectin to Treat or Prevent COVID-19 (U.S. Food and Drug Administration)
  4. Flawed ivermectin preprint highlights challenges of COVID drug studies (Nature)
  5. Early Treatment of COVID-19 with Repurposed Therapies: The TOGETHER Adaptive Platform Trial (McMaster University and Pontifical Catholic University of Minas Gerais)
  6. Is ivermectin a proven treatment for COVID-19? (Health-Desk.org)
  7. Coronavirus (COVID-19) | Drugs (U.S. Food and Drug Administration)
  8. Merck says COVID-19 pill cuts risk of death, hospitalization (AP News)
  9. Merck pill seen as 'huge advance,' raises hope of preventing COVID-19 deaths (Reuters)
  10. Australia to buy Merck's COVID-19 pill, Victoria cases hit record (Reuters)
  11. Thailand joins Asian nations in rush to buy Merck's COVID-19 pill (Reuters)
  12. EMA to consider rolling review for Merck's molnupiravir in coming days (Reuters)
  13. Covid antiviral pill can halve risk of hospitalisation (British Broadcasting Corporation)
  14. What we know — and don’t know — about Merck’s new Covid-19 pill (STAT News)
  15. What Merck’s new COVID pill can actually do (Popular Science)
  16. Why Merck’s Covid-19 pill molnupiravir could be so important (Vox)

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