April 2019 digital edition

Expanded use of insulin glargine
and lixisenatide injection
The US FDA has approved
the expanded use of insulin
glargine and lixisenatide
injection (Soliqua 100/33) for
patients uncontrolled on oral
antidiabetic medicines.
The injection was
previously approved for
use as an add-on to diet
and exercise in adults with
type 2 diabetes who are
uncontrolled on long-acting
insulin or lixisenatide.
The FDA approval was
based on data from the
LixiLan-O clinical trial which
showed, in adults with type
2 diabetes uncontrolled with
metformin and/or a second
oral antidiabetic therapy, that
treatment with the injection
led to significantly greater
reductions in blood sugar
levels.
medicine was discovered by
AstraZeneca and has previously
been in clinical development
in oncology. Phase II trials for
saracatinib in IPF have not yet
commenced.
EC clears
alirocumab for
patients with
CV risk
The European Commission
(EC) has approved
a new indication for
alirocumab (Praluent) to
reduce cardiovascular risk
in adults with established
atherosclerotic CV disease
(ASCVD) by lowering lowdensity
lipoprotein cholesterol
(LDL-C) levels as an adjunct to
correction of other risk factors.
ASCVD is an umbrella term,
defined as a buildup of plaque
in the arteries that can lead
to reduced blood flow and a
number of serious conditions
such as stroke, peripheral artery
disease and acute coronary
syndrome (ACS), which includes
heart attack and unstable
angina.
The EC approval is based
on data from ODYSSEY
OUTCOMES, a phase 3 trial that
assessed the effect of adding
alirocumab to maximallytolerated
statins in 18,924
patients who had an ACS
between 1-12 months before
enrolling in the trial.
Alirocumab is the only
PCSK9 (proprotein convertase
subtilisin/kexin type 9) inhibitor
available in two starting doses
as a single 1 milliliter injection
(75 mg and 150 mg) once
every two weeks and can also
be administered as 300 mg
once every four weeks enabling
physicians to tailor treatment
based on an individual
patient’s LDL-C-lowering needs.
Alirocumab inhibits the
binding of PCSK9 to the LDL
receptor and thereby increases
the number of available LDL
receptors on the surface of liver
cells to clear LDL, which lowers
LDL-C levels in the blood.
Rituximab gets
EC nod for
pemphigus
Rituximab (MabThera)
received approval
from the EC for the
treatment of adults
with moderate to
severe pemphigus
vulgaris (PV), a rare
condition characterised
by progressive painful
blistering of the skin and
mucous membranes.
Rituximab is the first
biologic therapy approved
by the EC for PV and the first
major advancement in the
treatment of the disease in
more than 60 years, Roche
said.
The European approval is
based on data from the phase
III Ritux 3 trial, a randomised
controlled study conducted
in France, which evaluated
rituximab plus a tapering
regimen of oral corticosteroids
(CS) compared to a standard
dose of CS alone, as a firstline
treatment in patients with
newly diagnosed moderate to
severe pemphigus.
The primary endpoint
of the study was complete
remission at month 24
without the use of CS for two
or more months. The study
demonstrated that 89.5% of
people with PV treated with
rituximab, in combination with
short-term oral CS treatment,
achieved complete remission
without the use of CS for two
or more months, compared
to 27.8% of people with PV
receiving CS alone, the current
40 / FUTURE MEDICINE / April 2019