Merck said Friday that a study of its experimental COVID-19 pill shows that the drug was significantly less effective at reducing hospitalizations and deaths than previously reported. (Merck & Co Inc. via Reuters)
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WASHINGTON – Merck & Co said Friday that updated data from their study of their experimental COVID-19 pill showed the drug was significantly less effective at reducing hospitalizations and deaths than previously reported.
The drug manufacturer said its pill showed a 30% reduction in hospitalizations and deaths based on data from 1,433 patients. In October, its data showed an effect of about 50%, based on data from 775 patients. The drug, molnupiravir, was developed with partner Ridgeback Biotherapeutics.
The lower effectiveness of Merck’s drug could have major consequences in terms of whether countries continue to buy the pill. Preliminary data from 1,200 participants in Pfizer Inc’s trials for its experimental pill, Paxlovid, showed an 89% reduction in hospitalizations and deaths.
Merck’s shares fell 3.5% to $ 79.39 in morning trading.
Merck released the data before the U.S. Food and Drug Administration on Friday released a set of documents to brief a panel of external experts, who will meet on Tuesday to discuss whether to recommend approving the pill.
The board staff did not come up with their own recommendation on whether the pill should be approved.
FDA staff asked the panel to discuss whether the benefits of the drug outweigh the risks and whether the population for which the drug should be approved should be limited.
They also asked the committee to consider concerns about whether the drug could encourage the virus to mutate and how those concerns could be mitigated.
Pills like molnupiravir and Paxlovid could be promising new weapons in the fight against pandemic, as they can be taken as early home treatments to prevent COVID-19 hospitalizations and deaths. They can also become important tools in countries and territories with limited access to vaccines or low inoculation rates.
The Merck and Pfizer pills are cheaper to produce and easier to administer than existing treatment options such as antibody therapies from Regeneron and Eli Lilly, which are mostly administered as intravenous infusions.
The two experimental drugs have different mechanisms of action. Merck’s is designed to introduce errors in the genetic code of the virus. Pfizer’s drug, part of a class known as protease inhibitors, is designed to block an enzyme that coronavirus needs to multiply.
Merck applied for a US approval of molnupiravir on October 11, according to preliminary data, and submitted the updated data to the FDA this week.
The Molnupiravir arm in the study had a hospitalization and death rate of 6.8% according to the updated data. The placebo group had a hospitalization and death rate of 9.7%.
One patient in the molnupiravir arm died, compared with nine in the placebo group.
The United Kingdom approved conditional molnupiravir, labeled Lagevrio, earlier this month.
Merck expects to produce 10 million treatment courses by the end of this year, with at least 20 million to be manufactured by 2022. It has a contract with the U.S. government to deliver as many as 5 million courses at a cost of $ 700 per course. Several other countries have already secured millions of birth control pills.
Merck has said that data show that molnupiravir is not capable of inducing genetic changes in human cells, but men who enrolled in the studies had to refrain from heterosexual intercourse or agree to use contraception. Women of childbearing potential should also use contraception.
Still, the FDA said in its briefing that there are safety concerns about potential birth defects from the drug and asked the panel to discuss whether the drug should be available to pregnant women.
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