FDA Panel Review – The Denver Post – Community News

FDA Panel Review – The Denver Post

WASHINGTON — An experimental COVID-19 drug that could soon become the first US-approved pill to treat the coronavirus faces a final hurdle on Tuesday: A panel of government experts will examine data on the drug from drug maker Merck.

The Food and Drug Administration is asking its outside experts whether the agency should approve the pill, weighing new information that it is less effective than first reported and may cause birth defects. The panel’s recommendations are not binding, but often guide FDA decisions.

Tuesday’s meeting comes as the number of infections in the US rises again and health authorities around the world are scrambling to assess the threat posed by the new ommicron strain.

If authorized, Merck’s Pill could be the first U.S. patients could take at home to relieve symptoms and speed recovery, a major step toward reducing hospitalizations and deaths. The drug, molnupiravir, is already approved for emergency use in the UK

Given the ongoing threat of the pandemic, the FDA is widely expected to approve the emergency use of the Merck Pill. But new data released last week paint a less convincing picture of the drug than when de Merck first published its initial results in October.

On Friday, Merck said final study results showed molnupiravir reduced hospitalization and death by 30% among adults infected with the coronavirus, significantly lower than the 50% reduction first announced based on incomplete results.

FDA regulators said they were still reviewing Merck’s update and would present a new assessment of the drug’s benefits to the outside panel. The effectiveness of Molnupiravir is an important question as panelists weigh whether the drug should be recommended and for whom.

An important question is whether the use of the drug by pregnant women or women of childbearing age should be restricted.

In the safety review, FDA officials said animal studies suggested Merck’s drug can cause birth defects when given in high doses. Regulators said they are considering a complete ban on molnupiravir during pregnancy and other precautions, including recommending contraceptives for some patients taking the pills.

Merck’s drug uses a new approach to fight COVID-19: It inserts tiny flaws into the coronavirus’ genetic code to prevent the virus from reproducing. That genetic effect has raised concerns that the drug could cause mutations in human fetuses or even fuel more virulent strains of the virus.

Another important question is whether the drug should be offered to patients who have been vaccinated or have previously had COVID-19. Merck did not study the drug in vaccinated people, but data from a handful of patients with previous infections suggested it had little benefit. Still, it can be impractical for doctors to screen those patients. The Merck drug works best when given within five days of the first COVID-19 symptoms, underscoring the need for prompt treatment.