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* 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)
