|
02-03-2021 12:40 |
|
EMA
issues advice on use of REGN-COV2 antibody combination (casirivimab /
imdevimab) |
|
EMA’s Human Medicines Committee (CHMP) has completed its review on the use of the monoclonal antibodies casirivimab and imdevimab to treat patients with COVID-19. This review was undertaken to provide a harmonised scientific opinion at EU level to support national decision making on the possible use of the antibodies prior to marketing authorisation. The Agency concluded that the combination also known as REGN-COV2 can be used for the treatment of confirmed COVID-19 in patients who do not require supplemental oxygen and who are at high risk of progressing to severe COVID-19. The
medicine is given by infusion (drip) into a vein and the proposed conditions
of use are available here. EMA made
its recommendations following review of data including quality data and a studythat
looked into the effects of the combination in outpatients with COVID-19 who
do not need supplemental oxygen. Preliminary results indicate that the
combination reduced the viral load (amount of virus in the back of the nose
and throat) more than placebo (a dummy treatment) and led to fewer
COVID-19-related medical visits. 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’s
recommendations can now be used to support national advice on the possible
use of the antibodies before a marketing authorisation is issued. In
parallel, a rolling
review of the combination of antibodies casirivimab and imdevimab, which
started on 1st February, is currently ongoing. Once finalised it
will be the basis for an EU marketing authorisation for this combination. More about the medicine This
medicine is made of casirivimab and imdevimab, two monoclonal antibodies. A monoclonal
antibody is an antibody (a type of protein) that has been designed to
recognise and attach to a specific structure (called an antigen). Casirivimab
and imdevimab have been designed to attach to the spike protein of SARS-CoV-2
at two different sites. When the active substances are attached to the spike
protein, the virus is unable to enter the body’s cells. More about the procedure The review
of REGN-COV2 antibody combination (casirivimab / imdevimab) was started at
the request of the EMA Executive Director under Article
5(3) of Regulation 726/2004 following preliminary discussion with the
COVID-19 EMA pandemic task force (COVID-ETF), which brings together experts
from across the European medicines regulatory network to advise on the
development, authorisation and safety monitoring of medicines and vaccines
for COVID-19. The article
5(3) review for the antibodies bamlanivimab and etesevimab, which started
on 4th February at the same time as the review on the monoclonal
antibodies ca sirivimab and imdevimab, is ongoing. The review
of REGN-COV2 antibody combination (casirivimab / imdevimab) was carried out
by EMA’s Committee for Medicinal Products for Human Use (CHMP), responsible
for questions concerning medicines for human use, which has now issued its
scientific opinion. The CHMP’s scientific opinion can be taken into account
by EU member states and EMA when evaluating this medicine for the treatment
of COVID-19. (ΜΚΥ) |
