EU regulator says Celltrion's COVID-19 antibody drug under real-time review (updated)

Celltrion

24/02/2021 16:05

(Adds details from EMA statement, background)
    Feb 24 (Reuters) - Europe's drug regulator said on Wednesday
it was evaluating South Korean drugmaker Celltrion's  068270.KS 
COVID-19 antibody treatment, the third such drug against the
disease to go under real-time review in the region.
    The European Medicines Agency (EMA) said its human medicines
committee was assessing the first set of data it received from
animal and human trials of the drug, regdanvimab, and will
continue to study them as more data was submitted. (https://bit.ly/3dHpXlr)
    Earlier this month, the EMA began evaluating antibody
therapies developed by U.S. drugmakers Eli Lilly  LLY.N  and
Regeneron  REGN.O  for use in some COVID-19 patients.
 urn:newsml:reuters.com:*:nL4N2KA486
    Celltrion's drug and those from Lilly and Regeneron belong
to a class of medicine called monoclonal antibody treatments,
which mimic natural antibodies the body generates to fight
infection. 
    Monoclonal antibody treatments can be synthesised in the
laboratory and are already used to treat some types of cancer.
    The EMA said it was "too early to draw any conclusions
regarding the benefit-risk balance of the medicine", as it has
not yet evaluated all the data on regdanvimab.  
    Celltrion's antibody treatment was conditionally approved in
its home country earlier this month after early-stage data in
November showed that it helped cut recovery time.  urn:newsml:reuters.com:*:nP8N2I401G
 urn:newsml:reuters.com:*:nL1N2HS03P
    EMA's "rolling reviews" are aimed to speed up the process of
approving a successful vaccine or treatment by allowing
researchers to submit findings in real time, even before the
final trial data is ready.
    Any endorsements by the EMA, however, have to be formally
approved by the European Commission.
    

 (Reporting by Pushkala Aripaka in Bengaluru; Editing by
Shinjini Ganguli)
 ((Pushkala.A@thomsonreuters.com; Twitter: @pullthekart; Mobile:
+91 852 751 3793 ;))