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 Laboratory-made monoclonal antibodies mimic natural antibodies in
fighting off infections. Unlike vaccines, they do not rely on the
body to create an immune response, and can therefore help
individuals with weak or compromised immune systems.
Below is an outline of where the major drugmakers are in the
development and regulatory process:
ASTRAZENECA
* AstraZeneca's antibody cocktail AZD7442 is delivered by
intramuscular shot.
* On Oct. 5 the company requested emergency use approval (EUA) from
U.S. regulators for the therapy, as a preventative drug.
* On Oct. 11 it said it would also submit the new treatment data to
global health regulators.
* On Oct. 14, the EU drug regulator said it had started a real-time
review of the therapy.
TRIALS:
* On Nov. 18, AstraZeneca said the cocktail offered 83% protection
against a symptomatic form of the illness over six months.
* A separate study in patients with mild-to-moderate COVID-19 showed
a higher dose of AZD7442 cut the risk of symptoms worsening by 88%
when given within three days of first symptoms.
* Earlier in October, data showed AZD7442 reduced the risk of severe
COVID-19 or death by 50% in non-hospitalised patients who have had
symptoms for seven days or less.
* In June, the drugmaker said a late-stage trial had failed to
provide evidence that the therapy could stop individuals who had
been exposed to the virus from contracting it.
SUPPLY DEALS:
* AstraZeneca said in March it would supply up to 500,000 more doses
of the therapy to the U.S., extending a prior agreement made in
October for 200,000 doses. The deal is contingent on an EUA from the
FDA.
* The British government also has an in-principle agreement for over
a million doses.
ELI LILLY & CO
* The U.S. pharmaceutical group's treatment, a combination of the
antibodies bamlanivimab and etesevimab, is meant for patients with
mild-to-moderate COVID-19.
* It so far given by infusion, or drip, only.
* In February it was granted an EUA by the FDA for treatment of
patients at high risk of severe illness who have not been
hospitalised or require oxygen therapy.
* The U.S. Department of Health and Human Services paused
distribution in June after the drug failed to show effectiveness
against several COVID-19 variants, but resumed it for some states at
the end of August.
* In September, the FDA revised its EUA to include use in at-risk
patients who have been exposed to the virus.
* In a letter dated Oct. 29, Eli Lilly withdrew its request for EU
authorisation, saying lack of demand in the trading bloc did not
justify submitting further required data on its manufacturing plan.
TRIALS:
* The combination helped cut the risk of hospitalisation and death
in patients by 70%, early data from a late-stage trial showed in
January.
* January data from a trial of one of the therapy's components,
bamlanivimab, also showed it could cut the risk of infection by 80%
for nursing home residents.
SUPPLY DEALS:
* The U.S. bought 100,000 doses of the dual antibody cocktails in
February, followed by 388,000 doses of etesevimab in September. The
country had already committed to buying a total of 1,450,000 doses
of bamlanivimab alone.
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 GLAXOSMITHKLINE
* GlaxoSmithKline and Vir Biotechnology
partnered to develop the COVID-19 antibody drug
sotrovimab.
* It was shown in a trial to work as well when
given as a shot in the arm as when administered
as an infusion.
* In May, the FDA granted sotrovimab an EUA for
treating mild-to-moderate COVID-19 in people
aged 12 years and older.
* The EU's drug regulator backed in June its use
for patients at risk of severe disease who do
not need supplemental oxygen.
* It received approval as a COVID-19 treatment
in Japan in September. TRIALS:
* The treatment resulted in a 79% reduction in risk of
hospitalisation for more than 24 hours or death due to any cause, a
late-stage study showed in June.
SUPPLY DEALS:
* The United States has signed contracts worth about $1 billion to
secure the treatment, with supply expected by Dec. 17.
* The EU signed in July a contract with GSK for the supply of up to
220,000 doses of sotrovimab.
* It also signed a deal to supply 10,000 doses to Canada.
REGENERON
* The single-dose antibody cocktail Ronapreve, known as REGEN-COV in
the United States and developed by Regeneron and Roche is a
combination of two antibodies (casirivimab and imdevimab), and can
be taken via injection or infusion.
* Mid-July, Japan became the first country to
authorise the treatment, swiftly followed by the United States and
Britain.
* REGEN-COV has now received emergency approval from more than 20
countries for both the prevention and treatment of the virus.
* On Nov. 11, the EU drug regulator recommended Ronapreve for
treatment in patients over 12 who do not require oxygen support and
are at high risk of severe disease, and for prevention in people
over 12 weighing at least 40 kilograms (88 lb).
TRIALS:
* Regeneron said on Nov. 8 that a single dose reduced the risk of
contracting COVID-19 by 81.6% in a late-stage trial, in the two to
eight months following the drug's administration.
* In June, a late-stage trial showed the cocktail reduced the risk
of death by 20% for hospitalised patients whose own immune systems
had failed to produce a response.
* Earlier in April, it was revealed that REGEN-COV helped cut the
risk of symptomatic infections by 81% among people in households
where another member had become ill.
SUPPLY DEALS:
* As of September, the U.S. government has purchased nearly 3
million doses.
* In June, the EU secured 55,000 doses through a contract covering
37 European countries, including Britain and other non-EU nations.
(Compiled by Lucinda Langlands-Perry and Valentine Baldassari in
Gdansk; Editing by Milla Nissi, David Evans and Philippa Fletcher)
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