|
 The U.S. drugmaker reported on Friday that the oral medicine's
efficacy in reducing hospitalizations and deaths had dropped to 30%
with data available from over 1,400 patients in its late-stage
study. It had reported about a 50% reduction a month ago using data
from 775 patients.
Analysts said they still expect the drug to be authorized, as
medicines like Merck's molnupiravir, developed with Ridgeback
Biotherapeutics, and Pfizer's Paxlovid are likely to become
important therapeutic tools that can be taken at home as soon as
COVID-19 symptoms arise.
The rival oral therapies target parts of the virus that are not
changed by mutations in the new Omicron variant. They could become
even more vital if vaccine-induced and natural immunity are
threatened by the variant.
The Merck pills are meant to be taken twice a day for five days upon
onset of COVID-19 symptoms.
The FDA's staff, in briefing documents posted ahead of the meeting
of outside experts, did not make a recommendation on whether the
drug should be authorized, and said they would provide their
assessment of the new data at the meeting.
They flagged concerns over whether the drug could cause the virus to
mutate, and asked the panel to discuss if a more targeted population
of patients should be offered the medicine to mitigate those
concerns.
[to top of second column] |
 Drugs in the same class as
molnupiravir have been linked to birth defects
in animal studies. Merck has said similar
studies of molnupiravir - for longer and at
higher doses than used in humans - indicate the
drug does not affect mammalian DNA.
"We anticipate significant discussion on molnupiravir's mechanism of
action and theoretical safety concerns, especially related to
potential birth defects from the drug and whether the drug should be
used in pregnant women or women of childbearing age," said Mizuho
analyst Vamil Divan.
More countries may end up signing deals for the Pfizer drug, which
taken with another antiviral, ritonavir, showed an 89% reduction in
hospitalizations and deaths in a trial, Divan said.
Pfizer's trial, like Merck's was stopped early due to its high
success rate.
(Reporting by Manas Mishra in Bengaluru; Editing by Caroline Humer
and Bill Berkrot)
[© 2021 Thomson Reuters. All rights
reserved.] Copyright 2021 Reuters. All rights reserved. This material may not be published,
broadcast, rewritten or redistributed.
Thompson Reuters is solely responsible for this content
 |
