FDA panel narrowly authorizes first antiviral to treat COVID-19

Asia's Tech News Daily

An FDA expert advisory committee signed off Tuesday on the first antiviral to treat COVID-19.

The drug, molnupiravir from Merck, is intended to be used in people at risk for severe COVID-19 within five days of the start of symptoms.

The Antimicrobial Drugs Advisory Committee, which met from 9 a.m. to 5 p.m. to hear drug safety and effectiveness data, voted 13 to 10 to authorize the drug for emergency use during the pandemic. Committee members said the drug should not be given during pregnancy.

Among high-risk patients, molnupiravir, which is intended to be given by prescription twice a day for five days, reduced the rate of hospitalization by nearly half compared to a placebo – which could have a significant impact on the course of the pandemic.

Pfizer has developed a different antiviral, Paxlovid, which is expected to be considered in coming weeks. Early data suggests the Pfizer drug is even more effective, preventing 90% of hospitalizations in a similarly at-risk population. Less safety data is available so far on Paxlovid.

Neither drug has been tested against the omicron variant.

The federal government has pre-purchased 1.7 million courses of molnupiravir for $1.2 billion, pending regulatory authorization, just over $700 per person. Pfizer has struck a deal to provide 10 million courses of Paxlovid for $5.3 billion if it is authorized, or about $530 per person.

The pre-purchase agreements mean patients would receive the drugs for free.

By comparison, Tamiflu, an antiviral against the flu, costs about $100 in the United States. Monoclonal antibodies, used to treat at-risk people at the beginning of their COVID-19 infection, costs $2,100 per use, which has been paid for so far by the federal government.

Antivirals are taken as pills to be swallowed, so they will be easier to use than monoclonals, which have to be injected or infused.

The committee spent a lot of time discussing the benefits and risks of molnupiravir.

Committee members were uncomfortable allowing the molnupiravir for pregnant women because studies in animals suggested there could be some risk to the fetus.

“There is no circumstance in which I would advise a pregnant woman to take this drug,” said Dr. James Hildreth, president and CEO of Meharry Medical College in Nashville, Tennessee. Other members said the drug should only be used if the mother was at particularly high risk from COVID-19 and monoclonal antibodies were not available.

The committee also discussed concerns about whether widespread use of the drug could lead to mutations in the virus, potentially making the virus more dangerous or less likely to be blocked by vaccines and therapies.

Members said they wanted Merck to track people who are immunocompromised as they take the drug, to ensure that the virus is not mutating in dangerous ways within them. People with weakened immune systems cannot fight off the virus effectively and can be sick for extended periods of time, allowing more mutations to develop.

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