FM November2020 Digital P

treated by a combination of
an inhaled corticosteroid (ICS)
and long-acting beta2-agonist
(LABA), or a combination of
a LABA and a long-acting
muscarinic antagonist.
The recommendation for
approval was also supported
by data from the KRONOS
phase III trial. In both trials, the
safety and tolerability of the
aerosphere were consistent
with the profiles of the dual
comparators.
The ETHOS and KRONOS
phase III trials are part of
AstraZeneca’s ATHENA phase
III clinical trial programme
for Trixeo Aerosphere, which
included more than 15,500
patients globally across 11
trials.
ETHOS is a randomised,
double-blinded, multi-centre,
parallel-group, 52-week
phase III trial to assess the
efficacy and safety of Trixeo
Aerosphere in symptomatic
patients with moderate to very
severe COPD and a history of
exacerbation(s) in the previous
year. The primary endpoint
was the rate of moderate or
severe exacerbations.
KRONOS is a randomised,
double-blinded, parallel-group,
24-week, chronic-dosing,
multi-centre phase III trial
to assess the efficacy and
safety of Trixeo Aerosphere
in patients with moderate to
very severe COPD regardless
of whether or not they had an
exacerbation in the previous
year.
Antibody
cocktail to treat
Ebola
Regeneron Pharmaceuticals
Inc announced that the
US FDA approved Inmazeb
(atoltivimab, maftivimab and
odesivimab-ebgn) for the
treatment of infection caused
by Zaire ebolavirus
in adult and paediatric
patients, including newborns
of mothers who have
tested positive for the
infection.
Inmazeb, previously called
REGN-EB3, was created using
Regeneron’s VelocImmune
platform and associated
VelociSuite technologies. The
treatment consists of three
monoclonal antibodies of
similar structure, atoltivimab,
maftivimab and odesivimab,
that bind to different, nonoverlapping
epitopes on
Zaire ebolavirus glycoprotein.
The three antibodies help
neutralize the Ebola virus by
blocking its ability to invade
patients’ and/or enlisting
other immune cells to target
infected cells and remove
them from the body
The drug is administered
as a single, weight-based
intravenous infusion (50 mg
atoltivimab, 50 mg maftivimab
and 50 mg odesivimab
per kg).
EMA committee
recommends
cabotegravir
for HIV-1
V
iiV Healthcare announced
that the Committee for
Medicinal Products for Human
Use (CHMP) of the European
Medicines Agency (EMA) has
issued a positive opinion
recommending marketing
authorisation for cabotegravir
injection and tablets (Vocabria)
in combination with rilpivirine
Inclisiran for high cholesterol
treatment in EU
The Committee for Medicinal Products
for Human Use (CHMP) of the European
Medicines Agency (EMA) has adopted
a positive opinion and recommended
granting marketing authorisation of
inclisiran (Leqvio) for the treatment of
adults with hypercholesterolemia or mixed
dyslipidemia, Novartis said
Inclisiran is a potential first-in-class
small interfering RNA (siRNA) with
a new mechanism of action which
delivers effective and sustained lowdensity
lipoprotein cholesterol (LDL-C)
reduction for patients with atherosclerotic
cardiovascular disease (ASCVD), ASCVD
risk equivalent and heterozygous familial
hypercholesterolemia (HeFH) a major
driver of heart attacks, strokes and deaths.
This CHMP opinion is based on
results from the ORION clinical research
programme including phase III
trials, which involved more than
3,600 patients on a maximally
tolerated statin dose and assessed
the safety, efficacy and tolerability of
inclisiran.
The drug demonstrated effective and
sustained LDL-C reduction of up to 52%
(P