Merck & Co. has launched molnupiravir, a new drug indicated to treat mild-to-moderate COVID-19 infection in adult patients.
Molnupiravir is approved by the U.S. Food and Drug Administration (FDA) under the Emergency Use Program (EUA).
Molnupiravir, as an oral medication for home use, has joined the growing arsenal of COVID-19 control drugs.
The appearance of molnupiravir is especially relevant in the current context of the next wave of coronavirus, now represented by the Omicron variant (B.1.1.529), which is spreading extremely rapidly around the planet.
Up-to-date scientific information about the new Omicron variant of SARS-CoV-2/COVID-19.
Molnupiravir is prescribed only if the following three conditions are met simultaneously:
- COVID-19 must be confirmed by a positive SARS-CoV-2 test, and
- the patient must be at high risk of progression to severe or critical illness with possible hospitalization or death, and
- COVID-19 treatment alternatives are not accessible or clinically appropriate for this patient.
FDA scientists took a detailed look at molnupiravir for treating COVID-19.
The following warnings and limitations are included in the molnupiravir’s prescribing information:
- Molnupiravir is not approved to treat patients under 18 years of age: molnupiravir may adversely affect bone and cartilage growth.
- Molnupiravir is not recommended for treating pregnant women: molnupiravir can harm the embryo or fetus.
- Molnupiravir is not indicated for the treatment of patients who need to be hospitalized because of COVID-19: the therapeutic usefulness of the drug in a hospital setting has not been confirmed.
- Molnupiravir should not be used longer than 5 consecutive days.
- Molnupiravir is not approved for pre-exposure or post-exposure prophylaxis of COVID-19.
According to a clinical trial of molnupiravir, it reduced the cumulative risk of hospitalization or death by 30%.
Molnupiravir pills can help COVID-19 patients avoid going to the hospital or dying.
Merck & Co. claims that molnupiravir maintains its antiviral activity against all variants of coronavirus, including Omicron and Delta.
Meanwhile, Pfizer has launched Paxlovid (nirmatrelvir + ritonavir), which, like molnupiravir, is an oral drug for COVID-19. Because Paxlovid is significantly more effective than molnupiravir (it reduces the risk of hospitalization or death by 89%) and is spared several restrictions on use (it can be used regardless of other COVID-19 treatment options, can be administered to children and pregnant women), consumer interest in molnupiravir is likely to be less strong than in Paxlovid.
Pfizer’s oral antiviral drug reduced the risk of hospitalization or death from COVID-19 by 89%.
The U.S. government ordered 3.1 million courses of molnupiravir from Merck & Co. at a cost of $712 each. The United Kingdom ordered 2.23 courses of molnupiravir. France, on the other hand, rejected molnupiravir, citing its low efficacy compared to Paxlovid.
According to industry estimates, molnupiravir will earn $2.5 billion in 2022, while Paxlovid will earn $17 billion.
The oral antiviral drug molnupiravir by Merck & Co.
The European Medicines Agency (EMA) continues to review molnupiravir’s application. However, the pan-European regulator has recommended molnupiravir treatment for eligible patients if national regulators decide to do so, without waiting for the EMA’s final verdict.
Under an agreement signed with the Medicines Patent Pool (MMP) of UNITAID, low-cost generic copies of molnupiravir will appear in 105 lower-middle-income countries in 2022.
For all the information about molnupiravir’s clinical efficacy, how it works, and who invented it, read BioPharma Media’s extensive article — Molnupiravir: New Effective Pill for Coronavirus. All That We Know.
Molnupiravir. Prescribing information. U.S. [PDF]