The next focusIR Investor Webinar takes places on 14th May with guest speakers from Blue Whale Growth Fund, Taseko Mines, Kavango Resources and CQS Natural Resources fund. Please register here.

Less Ads, More Data, More Tools Register for FREE

UPDATE 2-EU starts real-time review of AstraZeneca COVID-19 antibody cocktail

Thu, 14th Oct 2021 13:31

* Treatment is first COVID preventative shot other than
vaccines

* Drug, Evusheld, shown to save lives and prevent severe
disease

* EMA gives no timeline for possible approval
(Adds detail)

Oct 14 (Reuters) - Europe's drug regulator said on Thursday
it had started a real-time review of AstraZeneca's
antibody-based COVID-19 therapy, the first protective shot other
than vaccines against coronavirus.

The decision by the human medicines committee of the
European Medicines Agency (EMA) to begin the rolling review was
based on early results from clinical studies, the regulator said
https://www.ema.europa.eu/en/news/ema-starts-rolling-review-evusheld-tixagevimab-cilgavimab.
It did not say when a conclusion was expected.

The move to start a real-time review, so called because data
is evaluated as it is made available, came roughly a week after
the Anglo-Swedish drugmaker sought emergency approval from U.S.
authorities.

While vaccines rely on an intact immune system to develop
targeted antibodies and infection-fighting cells, AstraZeneca's
biotech compound, to be branded as Evusheld, contains lab-made
antibodies designed to linger in the body for months to contain
the virus in case of an infection.

The medicine has been proven to work among people who are
not infected and was also shown this week to save lives and
prevent severe disease when given as treatment within a week of
first symptoms.

"EMA will evaluate more data on the quality, safety and
effectiveness of the medicine as they become available," the
European Union's (EU) watchdog said, adding the review would
continue until AstraZeneca can formally submit an application
for approval.

AstraZeneca has said https://www.reuters.com/world/us/astrazeneca-files-us-approval-drug-prevent-covid-19-2021-10-05
that talks regarding supply agreements for Evusheld, also known
as AZD7442, are ongoing with the United States and other
governments.

There are some COVID-19 therapies based on the same class of
medicine as AstraZeneca, called monoclonal antibodies, that aim
to treat rather than prevent the illness. They are sold by
rivals Regeneron, Eli Lilly and GSK-Vir
outside the EU to stop the disease from worsening during
early, milder stages of the infection.

Other antibody-based COVID-19 treatments under a real-time
review by the EMA are GSK-Vir's treatment, Sotrovimab, and
Lilly's cocktail. Gilead's remdesivir is the only drug,
of any kind, to be approved in the EU https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/treatments-vaccines/covid-19-treatments
for COVID treatment.

The EMA is also considering whether to launch a rolling
review of Merck's experimental COVID-19 pill https://www.reuters.com/business/healthcare-pharmaceuticals/ema-consider-rolling-review-mercks-molnupiravir-coming-days-2021-10-05.
(Reporting by Pushkala Aripaka in Bengaluru
Editing by Arun Koyyur, Aditya Soni and Frances Kerry)

Related Shares

More News
2 May 2024 19:57

GSK knew about Zantac cancer risk, attorneys tell jury in first trial

May 2 (Reuters) - U.S. attorneys for a woman who claims her colon cancer was caused by the now discontinued heartburn drug Zantac on Thursday told a...

2 May 2024 09:48

LONDON BROKER RATINGS: Deutsche Bank likes TP ICAP but says sell CMC

(Alliance News) - The following London-listed shares received analyst recommendations Thursday morning and Wednesday:

1 May 2024 19:39

Bird flu testing shows more dairy products are safe, US FDA says

CHICAGO, May 1 (Reuters) - Preliminary results of tests on additional dairy products show that pasteurization inactivates the bird flu virus, the U....

1 May 2024 17:31

UK's FTSE 100 slips ahead of Fed outcome, energy stocks weigh

FTSE 100 down 0.3%, FTSE 250 off 0.2% *

1 May 2024 16:56

LONDON MARKET CLOSE: FTSE 100 down ahead of US interest rate decision

(Alliance News) - Stock prices in London closed mostly in the red on Wednesday, as investors eye the latest interest rate decision from the US Federal...

Login to your account

Don't have an account? Click here to register.

Quickpicks are a member only feature

Login to your account

Don't have an account? Click here to register.