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* Review to aid EU states with early emergency use
* Real-time rolling review of pill, Paxlovid, anticipated
* EU in talks with Pfizer over supply, rival Merck more
advanced
(Adds background)
By Pushkala Aripaka
Nov 19 (Reuters) - The European Union's drug regulator is
reviewing data on Pfizer's COVID-19 pill to help member
states decide on quick adoption ahead of any formal EU-wide
approval, it said https://www.ema.europa.eu/en/news/ema-starts-review-paxlovid-treating-patients-covid-19
on Friday, days after the drugmaker sought U.S. authorisation.
"While a more comprehensive rolling review is anticipated to
start ahead of a possible application for a marketing
authorisation, this current review will provide EU-wide
recommendations in the shortest possible time frame," the
European Medicines Agency (EMA) said.
Pfizer this week applied for U.S. emergency use
authorization of the experimental tablet, Paxlovid, following
data that showed it cut the chance of hospitalisation or death
by 89% in adults who are at risk of their illness worsening.
Unlike the United States, the world's biggest
pharmaceuticals market, the EMA does not have emergency use
procedures for treatments or vaccines, and often relies on a
lengthier process for authorisation.
But when COVID-19 cases have been rising, the EMA has been
offering its scientific expertise to nations who may need advice
on early-use before any wider recommendations by the European
regulator.
It has done that in the past for the antibody-based
treatment from GSK-Vir . The EMA last month began
a rolling review of a rival pill from Merck and expects
to conclude that evaluation by the end of the year.
While vaccines remain at the heart of the fight against the
pandemic, regulators are looking at promising therapies,
including the Pfizer and Merck pills, and EMA last week backed
antibody therapies Regeneron-Roche and
Celltrion.
While reviews on COVID-19 pills are ongoing, the EU is also
negotiating with Merck and Pfizer over possible contracts to
supply their tablets, an EU official told Reuters, adding that
talks with Merck were more advanced https://www.reuters.com/business/healthcare-pharmaceuticals/merck-ahead-pfizer-eu-talks-covid-19-pills-eu-source-2021-11-08.
German weekly Wirtschaftswoche first reported on the EU
review of Pfizer's pill.
(Reporting by Pushkala Aripaka in Bengaluru; Editing by Arun
Koyyur and Giles Elgood)
