Last checked at 
* Review and advice to aid EU states with possible early use
* Real-time rolling review of Pfizer pill, Paxlovid,
anticipated
* EU in talks with Pfizer and Merck over supply of their
pills
(Writes through with detail, advice on Merck pill)
By Pushkala Aripaka
Nov 19 (Reuters) - The European Union's drug regulator has
issued advice on using Merck's COVID-19 pill for adults
and began a review of a rival tablet from Pfizer to help
member states decide on quick adoption ahead of any formal
EU-wide approval.
In two separate statements on Friday, the European Medicines
Agency (EMA) detailed efforts to advance use of the experimental
but promising options, as infections and COVID-related deaths
are rapidly rising in the region and forcing renewed lockdowns.
EMA said https://www.ema.europa.eu/en/news/ema-issues-advice-use-lagevrio-molnupiravir-treatment-covid-19
Merck's COVID-19 tablet, Lagevrio, developed with Ridgeback
Biotherapeutics, should be given early and within five days of
first symptoms to treat adults who do not need oxygen support
and are at risk of their disease worsening.
It advised against treatment during pregnancy and for women
who plan to or could get pregnant, while adding that
breastfeeding must also be stopped around the time of using the
pill, which is to be taken twice a day for five days.
Drugs in the same class as Merck's Lagevrio have been linked
to birth defects in animal studies. The drugmaker, known as MSD
outside the United States and Canada, has said animal testing
shows its pill is safe, but the data have not been made public.
EMA said https://www.ema.europa.eu/en/news/ema-starts-review-paxlovid-treating-patients-covid-19
it was studying available data on the Pfizer pill Paxlovid,
days after the drugmaker sought U.S. approval, adding that a
more comprehensive rolling review was expected to start ahead of
any approval. It did not specify when that review would be.
The EMA last month began a rolling review of the Merck pill
and expects to conclude that evaluation by the end of the year.
EMERGENCY USE
Pfizer this week applied for U.S. emergency use
authorisation https://www.reuters.com/business/healthcare-pharmaceuticals/pfizer-files-us-authorization-covid-19-pill-2021-11-16
of its tablet following data that showed the pill cut the
chance of hospitalisation or death by 89% https://www.reuters.com/business/healthcare-pharmaceuticals/pfizer-says-antiviral-pill-cuts-risk-severe-covid-19-by-89-2021-11-05
in adults who are at risk of their illness worsening.
Merck's pill, which was approved by Britain earlier this
month, has been shown halve those chances when given early in
the illness.
While vaccines are central to the fight against the
pandemic, regulators are looking at therapies, including the
Pfizer and Merck pills, and EMA last week backed drugs from
Regeneron-Roche and Celltrion.
Unlike the regulators in the United States, the world's
biggest pharmaceuticals market, the European Union's EMA does
not have emergency use procedures for treatments or vaccines,
and often relies on a lengthier process for authorisation.
But faced with rising COVID-19 cases, the EMA has offered
its scientific expertise to nations that may need advice on
early-use before any wider recommendations by the regulator.
It has done that for the antibody-based treatment sotrovimab
https://www.ema.europa.eu/en/news/ema-issues-advice-use-sotrovimab-vir-7831-treating-covid-19
from GSK-Vir , the generic steroid dexamethasone
https://www.ema.europa.eu/en/news/ema-endorses-use-dexamethasone-covid-19-patients-oxygen-mechanical-ventilation
and Gilead's remdesivir https://www.ema.europa.eu/en/news/ema-provides-recommendations-compassionate-use-remdesivir-covid-19
antiviral.
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 official told Reuters last week, 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.
(Reporting by Pushkala Aripaka in Bengaluru; Editing by Arun
Koyyur, Giles Elgood and Barbara Lewis)
