FM NOVEMBER 2018 ISSUE - digital edition

showed that rivaroxaban
vascular dose, 2.5 mg twice
daily, plus aspirin 100 mg
once daily reduced the
risk of the composite
of stroke, CV death and
heart attack by 24 percent
compared with aspirin 100
mg once daily alone in
patients with CAD or PAD.
Rivaroxaban was
discovered by Bayer, and
is being jointly developed
with Janssen Research &
Development, LLC.
Abemaciclib
for HR+ breast
cancer in EU
EMA has cleared
abemaciclib (Verzenio) to
treat women with hormone
receptor-positive (HR+),
epidermal growth factor
receptor 2 negative (HER2-)
locally advanced or metastatic
breast cancer.
The treatment with
CDK4/6inhibitor is approved
as a first-line therapy
in combination with an
aromatase inhibitor or
fulvestrant, and as a secondline
treatment after earlier
endocrine drugs.
The approval of
abemaciclib is based on the
results of the Monarch 2
and Monarch 3 as secondline
and first-line studies. A
phase III trial called Monarch
E is currently underway to
determine the efficacy of
abemaciclibas adjuvant
therapy in early breast cancer.
Earlier, Eli Lilly suspended
the Phase 3 Juniper
programme to extend the use
of abemaciclibinto pancreatic
cancer as it failed to meet the
endpoints
Elapegademase
for ADA-SCID
US FDA has granted
approval for
elapegademase (Revcovi) for
adenosine deaminase severe
combined immune deficiency
(ADA-SCID).
Elapegademase is a longacting
drug that replaces
the missing ADA enzyme in
patients with ADA-SCID with
an engineered, recombinant
form.
The new drug comes as an
alternative to current animalderived
enzyme replacement
therapy pegademase bovine
by Leadiant.
Also known as bubble boy
disease, ADA-SCID is an ultrarare,
inherited geneticdisorder
that compromises patients’
immune systems and leaves
patients unprotected from
infections, and is fatal if
untreated.
The disease is typically
diagnosed within the first
few months of life, and
undiagnosed babies with
ADA-SCID usually die before
Breakthrough
designation for
20-valent vac
Pfizer’s 20-valent
pneumococcal
conjugate vaccine
(20vPnC) candidate,
PF-06482077, received
breakthrough therapy
designation from the US
FDA for the prevention
of pneumonia caused by
Streptococcus pneumoniae
serotypes in the vaccine in
adults.
The FDA decision is
informed by the results
of the 20vPnC Phase 2
randomized, double-blind
trial to evaluate the safety
and immunogenicity of a
multivalent pneumococcal
conjugate vaccine in adults
60 through 64 years of
age.
Anti-depressant vortioxetine
launched in India
Lundbeck launched vortioxetine
(Brintellix) in India for the
treatment of patients suffering
from major depressive disorder
(MDD), following approval from
Drug Controller General of India
(DCGI).
Vortioxetine is a novel
multimodal antidepressant which
has been specifically designed
to inhibit serotonin reuptake and
modulate serotonergic receptor
activity of the neurons in the brain
of affected patients.
It has demonstrated significant
efficacy in reducing the mood
symptoms in adult patients with
depression as measured by
traditional scales like MADRS or
HAMD.
The drug also improves
cognitive performance in adult
patients with depression, as
measured with neuropsychological
tests. Cognitive symptoms are
part of the diagnostic criteria
for depression and include the
ability to concentrate, make
decisions and the ability to
remember, said Lundbeck.
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