|
 Merck and partner Ridgeback Biotherapeutics plan to seek U.S.
emergency use authorization for the pill as soon as possible, and to
submit applications to regulatory agencies worldwide. Due to the
positive results, the Phase 3 trial is being stopped early at the
recommendation of outside monitors.
"This is going to change the dialogue around how to manage
COVID-19," Robert Davis, Merck's chief executive officer, told
Reuters.
If authorized, molnupiravir, which is designed to introduce errors
into the genetic code of the virus, would be the first oral
antiviral medication for COVID-19.
Rivals including Pfizer Inc and Swiss pharmaceutical Roche Holding
AG are racing to develop an easy-to-administer antiviral pill
https://www.reuters.com/business/
healthcare-pharmaceuticals/covid-19-pill-developers-aim-top-merck-pfizer-efforts-2021-09-28
for COVID-19 but so far, only antibody cocktails - which have to be
given intravenously - are approved for treating non-hospitalized
COVID-19 patients.
A planned interim analysis of 775 patients in Merck's study found
that 7.3% of those given molnupiravir were either hospitalized or
had died by 29 days after treatment, compared with 14.1% of placebo
patients. There were no deaths in the molnupiravir group, but there
were eight deaths of placebo patients.
"Antiviral treatments that can be taken at home to keep people with
COVID-19 out of the hospital are critically needed,” Wendy Holman,
Ridgeback's CEO, said in a statement.
In the trial, which enrolled patients around the world, molnupiravir
was taken every 12 hours for five days.
The study enrolled patients with laboratory-confirmed
mild-to-moderate COVID-19, who had symptoms for no more than five
days. All patients had at least one risk factor associated with poor
disease outcome, such as obesity or older age.
Merck said viral sequencing done so far shows molnupiravir is
effective against all variants
https://www.reuters.com/business/
healthcare-pharmaceuticals/merck-says-research-shows-its-covid-19-pill-works-against-variants-2021-09-29
of the coronavirus, including highly transmissible Delta.
[to top of second column] |
 The company said rates of
adverse events were similar for both
molnupiravir and placebo patients, but did not
give details of the side effects.
Merck has said data shows molnupiravir is not
capable of inducing genetic changes in human
cells, but men enrolled in its trials have to
abstain from heterosexual intercourse or agree
to use contraception. Women of child-bearing age
cannot be pregnant and also have to use birth
control. Merck said it expects
to produce 10 million courses of the treatment by the end of 2021,
with more doses coming next year.
The company has a U.S. government contract to supply 1.7 million
courses of molnupiravir at a price of $700 per course.
CEO Davis said Merck has similar agreements with other governments
worldwide, and is in talks with more. The company said it plans to
implement a tiered pricing approach based on country income
criteria.
Merck has also agreed to license the drug to several India-based
generic drugmakers, which would be able to supply the treatment to
low- and middle-income countries.
Molnupiravir is also being studied in a Phase 3 trial for preventing
coronavirus infection in people exposed to the virus.
Merck officials said it is unclear how long the FDA review of the
drug will take.
"I believe that they are going to try to work with alacrity on
this," said Dean Li, head of Merck's research labs.
(Reporting by Deena Beasley; Editing by Lincoln Feast.)
[© 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
 |
