December 23, 2021, New York, NY—The US Food and Drug Administration (FDA) today issued emergency use authorization (EUA) for molnupiravir, an oral COVID-19 treatment. Molnupiravir is recommended for the early treatment of people with mild to moderate COVID-19 who are at increased risk of developing severe COVID-19 disease, and for whom alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate. While Merck, the company that produces this medication, has said the drug can reduce the risk of hospitalizations and deaths among people at high risk of COVID-19 by 30 percent, it will be priced out of reach for many.
Although Merck has already signed deals with several manufacturers in India, and also recently announced a voluntary license agreement with the United Nations-backed Medicines Patent Pool (MPP), these deals don't do enough to ensure that affordable versions of this medicine will be available for everyone who needs it, everywhere. These deals exclude people in some middle-income countries, such as Brazil, China, and Turkey. Restricting the breadth of generic manufacturing and supply of this medicine will significantly limit global access to the world’s first oral antiviral treatment for COVID-19, said the international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (MSF).
Currently, the World Health Organization (WHO) recommends the use of a monoclonal antibody treatment, casirivimab and imdevimab, for people with early stage COVID-19, but monoclonal antibodies in general are expensive, more complex to produce, and require administration via intravenous infusion or subcutaneous injection. As an oral drug, molnupiravir would be much more affordable and easier to access, particularly in resource-limited settings such as those where MSF works.
Molnupiravir has already been approved for use in the UK.
Mihir Mankad, senior global health advocacy and policy advisor at MSF-USA, said of today’s FDA approval:
“In order to end the COVID-19 pandemic for everyone, people everywhere must have access to lifesaving medicines like molnupiravir.
“As billions of people across the world remain unvaccinated and vulnerable to COVID-19 in many of the low-resource settings in which MSF medical teams work, molnupiravir must be more widely affordable and available—not just in richer countries like the US that can afford Merck’s high prices. It’s imperative that our medical teams in even the most remote places have effective and easy-to-administer medicines like molnupiravir to offer people who come into our clinics seeking care.
“Merck is expected to charge $700 for a five-day treatment course of molnupiravir in countries excluded from the benefits of generic competition, despite the fact that independent researchers at Harvard University have estimated the sustainable generic price for a full treatment course is $20. This high price is especially unacceptable since US tax dollars funded Emory University’s development of the medicine before pharmaceutical corporations Ridgeback and Merck obtained the licensing and rights for the medicine.
“The best way to ensure molnupiravir is available across the globe is by supporting generic production in all countries where there is capacity. Governments must quickly adopt the TRIPS waiver at the World Trade Organization level. This could empower countries to rapidly lift the main intellectual property barriers, including patents, so countries around the world can freely produce versions of this lifesaving medicine and other COVID-19 tools.
“The FDA’s approval of molnupiravir gives us another tool to treat people infected with COVID-19, but now it needs to be in everyone’s toolbox.”