WHO Recommends Merck (MRK) Oral Pill for Certain COVID Patients
The World Health Organization (“WHO”) recently updated its treatment guidelines for COVID-19 to include Merck’s MRK and Ridgeback Biotherapeutics’ oral antiviral drug molnupiravir.
The conditional recommendation by WHO for molnupiravir makes it the first oral antiviral drug to be included in the treatment guidelines for COVID-19.
WHO has recommended that molnupiravir should be provided only to non-severe COVID-19 patients with the highest risk of hospitalization due to limited safety data available as of now. The recommendation is mostly for unvaccinated, older people, people with immunodeficiencies and those living with chronic diseases.
This recommendation is based on new data from six randomized controlled trials involving 4796 patients.
Merck and partner Ridgeback Biotherapeutics’ molnupiravir received many authorizations or approvals worldwide in 2021 for treating high-risk adults with mild-to-moderate COVID-19. The FDA has issued an Emergency Use Authorization (EUA) for the use of molnupiravir or the treatment of mild to moderate COVID-19.
Last month, both the companies announced that approximately 3.1 million courses of molnupiravir have been provided to the U.S. government for allocation across the country.
Merck has entered into advance purchase and supply agreements for molnupiravir in more than 30 markets worldwide, including Australia, Canada, Korea, Japan, Thailand, Ukraine and the United Kingdom, pending regulatory authorizations.
The recommendation should boost demand for the antiviral pill.
Concurrently, WHO included an update on Regeneron’s REGN casirivimab-imdevimab, a monoclonal antibody cocktail, also known as REGEN-COV. WHO now recommends that this cocktail should only be given when the infection is caused by a variant other than Omicron as the cocktail was found ineffective against it.
We note that the FDA earlier revised the authorizations for two monoclonal antibody treatments – Eli Lilly’s LLY bamlanivimab and etesevimab (administered together) and Regeneron’s REGEN-COV (casirivimab and imdevimab) as the data showed that these treatments were unlikely to be active against the Omicron variant.
In February, the regulatory body, however, issued an EUA for Lilly’s bebtelovimab, an antibody that demonstrates neutralization against the Omicron variant. The treatment can be used for certain non-hospitalized patients with mild-to-moderate COVID-19 at high risk of progression to severe disease.
Pfizer’s PFE Paxlovid was another oral antiviral pill that was issued an EUA by the FDA for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients. Paxlovid is currently approved or authorized for emergency use in more than 10 countries across the globe. Pfizer expects Paxlovid to generate sales of $22 billion in 2022.
Merck currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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