
Here Come the COVID-19 Treatment Options
FDA authorized emergency use of Pfizer’s oral antiviral drug to make the drug available as quickly as possible.
FDA authorized emergency use of Pfizer’s oral antiviral drug, Paxlovid, on Dec. 22, 2021, skipping the advisory committee review to make the drug available as quickly as possible. This decision was followed on December 23 with FDA providing similar authorization for Merck’s Molnupiravir, with
Pfizer’s Paxlovid (nirmatrelvir/ritonavir)
Being able to treat COVID-19 with a drug taken orally at home is “a major step forward in the fight against this global pandemic,” said Patrizia Cavazzoni, director of FDA’s Center for Drug Evaluation and Research (CDER). And the approval, she added, comes “at a crucial time in the pandemic as new variants emerge.” At the same time, FDA continued to emphasize the importance of vaccination in protecting individuals from COVID-19 infection.
Merck as backup
Despite concerns that the antiviral drug molnupiravir developed by Merck and Ridgeback Biotherapeutics may be less effective and riskier than the Pfizer treatment, FDA granted an EUA for the product to provide an additional option for treating patients (over 18 only) with early symptoms and in need of treatment quickly to prevent hospitalization or more serious disease. Cavazzoni stated that molnupiravir use should be limited to situations where other authorized treatments “are inaccessible or are not clinically appropriate.”
Merck’s drug ran into trouble at the Nov. 30, 2021, meeting of FDA’s Antimicrobial Drugs Advisory Committee, where concerns were raised about possible birth defects if used by pregnant women and potential damage to patients’ DNA. The drug suffered from data released just before the meeting that showed only a 30% decrease in hospitalizations, compared to 50% in preliminary results, a drop that the sponsors had difficulty explaining. Consequently, the panel recommended approving the drug by only a very slim margin.
However, scientists involved with the drug’s development and testing made the case for molnupiravir being a useful weapon in combatting COVID-19. An article in the
Merck’s drug may be particularly helpful in the lesser developed countries where access to new therapies is limited. Merck has said it plans to make its patents available to the World Health Organization patent pool and to generic-drug manufacturers so that it can be produced for developing countries at low cost. Similarly, Pfizer stated that it will provide the new drug through a tiered pricing program, where high-income countries will pay more than lower income countries. And the company has signed a voluntary license agreement with the Medicines Patent Pool to expand access to its oral antiviral treatment to 95 low- and middle-income countries.
Supply challenges
The main factor clouding the immediate impact of these new drugs is limited supplies. Pfizer said that it planned to provide 10 million treatment courses “between 2021 and 2022,” as per a $5.3 billion advance purchase agreement with the US government. The company also aims to
Similarly, Merck has said it is ramping up production to expand its supply. The United Kingdom, where the drug was already authorized, is purchasing more than 2 million courses of treatment, and the company has an agreement to supply some 3 million courses of treatment to the US. Merck says it expects to produce 10 million courses of treatment by the end of 2021 and at least 20 million in 2022.
About the author
Jill Wechsler is BioPharm International's Washington editor.
Newsletter
Stay at the forefront of biopharmaceutical innovation—subscribe to BioPharm International for expert insights on drug development, manufacturing, compliance, and more.