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Business


MERCK’S COVID PILL NARROWLY GETS BACKING FROM FDA ADVISERS

By
Fiona Rutherford
and
Riley Griffin
November 30, 2021, 9:54 PM GMT Updated on December 1, 2021, 12:42 AM GMT
 * Thin vote margin highlights safety concerns about treatment
 * Decision comes as scientists race to study new omicron variant

The Pandemic in the Next 6 Months


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Merck & Co.’s Covid-19 pill narrowly gained a key recommendation from advisers
to U.S. regulators, after a lengthy debate about the safety of the potential
game-changing treatment.

The Food and Drug Administration’s advisory committee voted 13-10 to back
Merck’s antiviral drug molnupiravir, saying that while there were safety
concerns about the pill, its potential benefits outweigh the risks.

The pill is intended to treat mild-to-moderate Covid-19 in adults at risk of
developing severe illness. Merck developed the treatment with partner Ridgeback
Biotherapeutics LP.




Merck’s shares rose 1.9% in late trading as the vote increased the likelihood
that the treatment will be cleared for use in the U.S.



After the vote, several panel members said it was a difficult decision. Those
who voted yes cited a need for a treatment like molnupiravir for high-risk
individuals. But they cautioned that it shouldn’t be recommended for pregnant
people, especially those in the first trimester. Panel members who voted no
expressed concern about the lack of sufficient efficacy and safety data.



“Honestly, we were a little surprised,” said Daria Hazuda, vice president of
Merck’s infectious diseases and vaccines division, in an interview after the
vote, adding the drugmaker did a “thorough analysis” of the drug’s potential to
do genetic damage. 



Asked whether Merck planned to produce additional safety data to ensure
regulators are comfortable authorizing the drug, Hazuda said, “we have to
discuss with the agency if there are additional studies it feels is warranted.”
But she believes that had the FDA wanted additional safety studies, the agency
would have asked for that already.

The decision by the advisory committee comes amid rising concerns about a new
coronavirus variant that is described by scientists as potentially of serious
concern. Pfizer Inc. and partner BioNTech SE, Moderna Inc. and Johnson & Johnson
are working to adapt their Covid-19 vaccines to address the omicron variant.



Read more: Vaccine debate clouds threat posed by omicron variant

The FDA isn’t obligated to follow the recommendations of the panel, called the
Antimicrobial Drugs Advisory Committee, though it typically does. A decision
from the agency on whether to clear the pill could come soon after the meeting
concludes on Tuesday.


NEW WEAPON

The pill could alter the fight against the pandemic by turning Covid-19 into an
illness that is easily treated outside of a hospital setting. That may relieve
the strain on health systems stretched thin by staffing shortages and rising
infection levels.



Unlike other Covid-19 antivirals that are administered via intravenous infusion
usually in hospitals or clinics, a five-day course of molnupiravir can be taken
by patients at home. 



Merck presented data from a study showing that its pill reduced the risk of
hospitalization or death among adults with mild to moderate disease by 30%. That
was lower than a previous estimate of 48%. The panel of advisers to the FDA
peppered the drugmaker with questions about why the promising benefit
molnupiravir demonstrated in the interim analysis decreased in the full study of
all participants. 

“What really changed in the overall study in the second half was the fact that
the placebo group was apparently at lower risk of hospitalization and death,”
Hazuda said. 

With fewer patients receiving the placebo getting severely sick from the virus,
it became more difficult for Merck to demonstrate as significant of a benefit
with its treatment. “It’s not that the drug was less effective,” she said. 



Hazuda said Merck did not have “a good explanation” as to why fewer participants
in the placebo arm appeared to get very sick. 


MUTATION CONCERNS

Molnupiravir works by introducing errors in genetic material to ultimately stop
replication, which some experts have said may affect growing human cells.



For months, Merck has suggested that it’s confident that molnupiravir doesn’t
pose long-term risk associated with systemic exposure to a DNA mutagen. The
company had evaluated two distinct assays looking at the drug’s capacity to
alter DNA in living organisms and found that the data looked clean. 

Nicholas Kartsonis, senior vice president of clinical research for infectious
diseases and vaccines at Merck Research Labs, had told Bloomberg he was “very
impressed” by the drug’s safety results in an interview in March.



The FDA, however, raised questions about whether the treatment could cause birth
defects, as well as bone and cartilage toxicity, and genetic mutations. 

At the advisory committee hearing, Robert Heflich, the FDA’s director of the
Division of Genetic and Molecular Toxicology, questioned the company’s
perspective on the assays. “They really can’t tell if it’s positive or
negative,” he said, referring to the results of the studies. 


VIRAL EVOLUTION

Separately, panel members expressed concern that molnupiravir could cause the
virus to further mutate to evade immune defenses if patients didn’t complete
their full treatment course. 



“You’re purposely mutagenizing the virus,” said James Hildreth, president of
Meharry Medical College, before the committee vote. “So with all respect, I
think it’s incumbent upon you to make some effort to make an estimate of what is
the likelihood of escape mutants occurring as a result of your drug.”



Merck’s Kartsonis stressed that the patients will be urged to take the full
treatment course. That messaging isn’t just to “prevent evolution” of the virus,
Kartsonis said, but also because it will ensure that patients get the greatest
benefit from the treatment.

Hazuda added that the viruses naturally mutate to survive, and so “the best way
to stop viral evolution is stop replication.” Treatment, she said, is the answer
to both stopping replication in the body and transmission between people. 



Regulators have already allowed Merck’s pill to be used in emergency treatment
of adults in the European Union. It hasn’t been formally authorized for sale. 

Pfizer is also pursuing FDA authorization for its own antiviral Covid-19 pill.



— With assistance by Jeannie Baumann, and Celine Castronuovo

(Updates with details from Merck interview throughout)


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