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 Britain's Medicines and Healthcare products Regulatory Agency (MHRA)
recommended
https://www.gov.uk/
government/
news/first-oral-antiviral-for-covid-19-lagevrio-molnupiravir-approved-by-mhra
the drug, molnupiravir, for use in people with mild to moderate
COVID-19 and at least one risk factor for developing severe illness,
such as obesity, older age diabetes, and heart disease.
It will be administered as soon as possible following a positive
COVID-19 test and within five days of the onset of symptoms, the
regulator said, citing clinical data.
The green light is the first for an oral antiviral treatment for
COVID-19 and the first for a COVID-19 drug that will be administered
widely in the community. U.S. advisers will meet on Nov. 30 to
review the drug's safety and efficacy data and vote on whether
molnupiravir should be authorized.
The pill, which will be branded as Lagevrio in Britain, is designed
to introduce errors into the genetic code of the coronavirus that
causes COVID-19 and is taken twice a day for five days.
Drugs in the same class as molnupiravir have been linked to birth
defects in animal studies. Merck, known as MSD outside of the United
States and Canada, has said animal testing shows that molnupiravir
is safe, but the data have not yet been made public.
Treatments to tackle the pandemic, which has killed more than 5.2
million people worldwide, have so far focused mainly on vaccines.
Other options, including Gilead's infused antiviral remdesivir and
generic steroid dexamethasone, are generally only given after a
patient has been hospitalised.
Merck's Molnupiravir has been closely watched since data last month
showed it could halve the chances of dying or being hospitalised for
those most at risk of developing severe COVID-19 when given early in
the illness.
Professor Stephen Powis, national medical director for the National
Health Service (NHS) in England, said the drug would be administered
to patients at higher risk of complications as Britain heads into
one of the most challenging winters ever.
A wider rollout will follow if it is clinically and cost effective
in reducing hospitalisations and death, he added.
"We are now working across government and the NHS to urgently get
this treatment to patients initially through a national study so we
can collect more data on how antivirals work in a mostly vaccinated
population," UK vaccines minister Maggie Throup told parliament.
PRESSURES
The speedy approval in Britain, which was also the first Western
country to approve a COVID-19 vaccine, comes as it struggles to tame
soaring infections.
Britain has about 40,000 daily cases of COVID-19, according to the
latest seven-day average. That is second only to the roughly 74,000
a day in the United States, which has five times more people, and
has fuelled criticism of the government's decision to abandon most
pandemic-related restrictions
Data released on Wednesday night showed COVID-19 prevalence in
England hit its highest level on record last month, led by a high
number of cases in children and a surge in the south-west of the
country.
Pressure is growing on the government to implement its "Plan B"
aimed at protecting the NHS from unsustainable demands, involving
mask mandates, vaccine passes and work-from-home orders.
Many other big economies,
including Germany, France and Israel, have
either retained some basic COVID-19 measures
like mask mandates or reintroduced them in
response to rising cases.
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The UK government has said its focus remains on
administering vaccine boosters and inoculating
12- to 15-year-olds.
"With no compromises on quality, safety and
effectiveness, the public can trust that the
MHRA has conducted a robust and thorough
assessment of the data (on molnupiravir)," MHRA
chief June Raine said in a statement.
Last month, Britain agreed a deal with Merck to secure
https://www.reuters.com/world/uk/
britain-secures-covid-19-antivirals-merck-pfizer-2021-10-20 480,000
courses of molnupiravir.
Professor Penny Ward, an independent pharmaceutical physician,
welcomed the approval, but said the NHS needed to outline its plans
for rollout and cautioned that supplies were likely to be tight
given the strong global demand.
"Comments made by Mr Javid today suggest that it may be made
available via a clinical trial, presumably to investigate its
effectiveness in vaccinated patients with breakthrough infections,
as the original study incorporated unvaccinated adults," she said.
If given to everyone becoming unwell, the nearly half a million
courses would not last very long given the more than 40,000 current
daily case rate, she said.
TREATMENT RACE
In a separate statement, Merck said it expected to produce 10
million courses of the treatment by the end of this year, with at
least 20 million set to be manufactured in 2022.
The U.S.-based drugmaker's shares rose 2.1% to close at $90.54 on
Thursday.
Pfizer and Roche are also racing to develop easy-to-administer
antiviral pills for COVID-19.
Both Merck and Pfizer are studying their drugs in late-stage trials
for preventing coronavirus infection. Viral
sequencing done so far has shown molnupiravir is effective against
all variants of the coronavirus, Merck has said, including the
more-infectious Delta, which is responsible for the worldwide surge
in hospitalisations and deaths recently.
While it is not yet clear when Merck will deliver doses to Britain,
the company has said
https://www.reuters.com/business/
healthcare-pharmaceuticals/merck-covid-19-pill-sparks-calls-access-lower-income-countries-2021-10-17
it is committed to providing timely access to its drug globally with
plans for tiered pricing aligned with a country's ability to pay.
Merck has licensed the drug to generic drugmakers for supply to
low-income countries.
Antibody cocktails like those from Regeneron and Eli Lilly have also
been approved for non-hospitalised COVID-19 patients, but have to be
given intravenously.
(Reporting by Pushkala Aripaka in Bengaluru and Josephine Mason in
London; additional reporting by Kate Holton;Editing by Anil D'Silva
and Mark Potter)
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