If approved, the drug would ease the hospital burden on health systems in several countries and allow outpatient treatment, says the doctor.
Molnupiravir is an investigational phase 3 oral drug that has shown promising results in the treatment of mild to moderate COVID-19. Merck&Co recently submitted to the Food and Beverage Administration of the United States (FDA) the application for authorization of emergency use (EUA) that is being processed. Dr. Luis Cordero Rueda, leader of the therapeutic area for vaccines, infectious diseases and general medicine at MSD in Ecuador, says that having the drug would ease the hospital burden on the health systems of several countries and allow outpatient treatments.
What is the status of the application submitted by Merck & Co to the FDA in the US for the emergency use of molnupiravir?
Merck Sharp & Dohme Corp. (MSD), known as Merck in the United States and Canada, and Ridgeback Biotherapeutics announced on October 11, 2021 that they have filed with the United States Food and Beverage Administration (FDA) ) the application for emergency use authorization (US) for molnupiravir, an investigational oral antiviral for the treatment of mild to moderate COVID-19 in non-hospitalized adult patients at risk of progressing to severe COVID-19 and / or hospitalization. The presentation is based on positive results of a planned interim analysis of the phase 3 MOVe-OUT study.
Is molnupiravir an existing drug?
Molnupiravir is an investigational phase 3 drug that has shown promising results in the treatment of mild to moderate COVID-19. Molnupiravir significantly reduced the risk of death or hospitalization in a planned interim analysis of the MOVe-OUT phase 3 study in non-hospitalized adult patients with mild to moderate risk factor and COVID-19.
In anticipation of the MOVe-OUT results, MSD has been critically producing molnupiravir. MSD expects to produce 10 million courses of treatment by the end of 2021, with more doses expected to be produced in 2022. This estimate is based on the dose of 800 mg every twelve hours for five days that is currently being evaluated.
We are using our global network, which includes manufacturing sites in eight countries on three continents. We are also identifying additional opportunities to complement this network.
When and for what was it created?
Between 2015 and 2019, the Emory University drug innovation group received federal grants to support early research on broad-spectrum antivirals for infectious diseases. With the support of these grants, Emory invented EIDD2801, which is known today as molnupiravir.
In March 2020, Ridgeback Biotherapeutics licensed EIDD2801. Merck in May 2020 partnered with Ridgeback to help develop molnupiravir. MSD has invested billions of resources in research, development and manufacturing efforts mobilizing all scientific expertise and resources to contribute to the global response to the pandemic.
Is it sold in Ecuador, is it over-the-counter?
There is still no regulatory approval to market it in the country, the conditions to do so will be those set by the local regulatory authority. We are working through a multifaceted strategy that includes tiered or differential pricing, to ensure affordable supply in developing countries, and the coordination of supply and purchase agreements with local governments, as well as distribution processes to guarantee timely access to molnupiravir.
What results have clinical studies of the drug yielded so far, would it be effective for all variants of COVID-19, and what side effects could its use cause?
In a planned interim analysis of the phase 3 trial, MOVe-OUT, in non-hospitalized adult patients with risk factor and mild to moderate COVID-19, molnupiravir reduced the risk of hospitalization or death by approximately 50%; 7.3% of patients receiving molnupiravir were hospitalized or died within 29 days after randomization (28/385), compared with 14.1% of patients treated with placebo (53/377) ; p = 0.0012. At day 29, no deaths were reported in patients receiving molnupiravir, compared with 8 deaths in patients receiving placebo. On the recommendation of an independent Data Monitoring Committee and in consultation with the FDA, patient recruitment has been stopped early due to these positive results.
Inclusion criteria required all patients to have laboratory-confirmed mild to moderate COVID-19, with symptom onset within five days prior to study randomization. All patients were required to have at least one risk factor associated with unfavorable disease outcomes when participating in the study. Molnupiravir reduced the risk of hospitalization and / or death in all key subgroups; efficacy was not affected by timing of symptoms or underlying risk factor. In addition, based on the participants with available viral sequencing data (approximately 40% of the participants), molnupiravir demonstrated consistent efficacy in the gamma, delta, and mu viral variants.
What are the advantages of having an officially approved drug against COVID-19?
It would constitute an additional element for the control of the pandemic, without neglecting the need for vaccination, social distancing and other measures. Being an oral medicine, it can alleviate the hospital burden of the health systems of several countries and would allow outpatient treatment.
If approved, how would its sale price be regulated so that there is no speculation or overpricing as occurred with ivermectin?
If molnupiravir is licensed or approved, we plan to implement a global pricing and access strategy whereby the price of molnupiravir will be staggered based on the income categories of World Bank countries, reflecting a country’s ability to finance its response to the pandemic and your healthcare system. This means that high-income countries will pay a similar but different price to low- and middle-income countries.
The Ecuadorian Government maintains, through the Drug Pricing Council, clear guidelines that regulate the prices of drugs marketed in Ecuador. We will be respectful of those processes.
If more drugs like molnupiravir start to emerge, could the vaccines be dispensed with?
The vaccination strategy has proven to be an effective measure to control the pandemic, vaccines are and will continue to be very important. The best way to avoid complications associated with COVID-19 is to avoid contagion, and the best way to avoid contagion is vaccination, use of a mask, constant hand washing and social distancing measures.
As emerging variants worsen the COVID-19 pandemic around the world, we must evaluate potential treatments with these variants in mind. To date, delta, gamma, and mu variants have accounted for about 80% of evaluable cases in the study (22%, 22%, and 35%).
Molnupiravir, unlike other currently approved and licensed treatments, can be administered orally, while others are administered by infusion or require access to a health facility, making it a valuable additional tool in the fight against COVID- 19. (I)
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