EU regulator advises use of Regeneron antibody cocktail for COVID-19 (updated)

Celltrion

26/02/2021 11:56

(Adds EMA comment, background)
    Feb 26 (Reuters) - Europe's medicines regulator said on
Friday an antibody drug combination developed by Regeneron
Pharmaceuticals  REGN.O  can be used to treat COVID-19 patients
who do not require oxygen support and are at high risk of
progressing to severe illness.
    The recommendation can now be used as guidance in individual
European nations on the possible use of the combination of
casirivimab and imdevimab before a marketing authorisation is
issued, the European Medicines Agency (EMA) said. (https://bit.ly/3syYgzB)
    Regeneron's antibody cocktail was authorised for emergency
use in the United States in November, and was given to former
U.S. President Donald Trump during his COVID-19 infection.
    The treatment, given via a drip, is part of a class of drugs
known as monoclonal antibodies, which are manufactured copies of
antibodies created by the human body to fight infections.
    "In terms of safety, most side effects reported were mild or
moderate, however reactions related to the infusion (including
allergic reactions) have been seen and should be monitored for,"
EMA said.
    The regulator said its real-time review of the combination
is ongoing and will form the basis for its recommendation for an
EU conditional marketing approval. It is also reviewing antibody
treatments from Eli Lilly  LLY.N  and Celltrion  068270.KS .
    Regeneron said on Thursday an independent panel found the
treatment to have "clear clinical efficacy" in reducing the
rates of hospitalization and deaths in patients.  urn:newsml:reuters.com:*:nL4N2KV3FQ

 (Reporting by Pushkala Aripaka and Yadarisa Shabong in
Bengaluru; Editing by Shounak Dasgupta)
 ((Pushkala.A@thomsonreuters.com; Twitter: @pullthekart; Mobile:
+91 852 751 3793))