FM DECEMBER 2018 ISSUE - digital edition

mechanism-of-action. It
directly activates the immune
system through natural killer
cells via the SLAMF7 pathway.
Elotuzumab also targets
SLAMF7 on myeloma cells,
tagging these malignant cells
for natural killer cell-mediated
destruction via antibodydependent
cellular toxicity.
The approval for multiple
myeloma is based on data
from the randomized, openlabel,
Phase 3, ELOQUENT-2
study, which demonstrated
that the ERd regimen resulted
in a 30% reduction in the
risk of disease progression or
death compared to Rd alone.
Elotuzumab is available for
injection for intravenous use in
300 mg and 400 mg vials.
Bijuva to
treat hot
flashes in US
women
The US FDA has approved
estradiol and progesterone
(Bijuva) oral capsules, 1
mg/100 mg, for the treatment
of vasomotor symptoms due
to menopause in women with
a uterus.
The approval is based
on the clinical development
programme that included the
pivotal Phase III Replenish
Trial. The results of the trial
were published in the journal
Obstetrics & Gynecology.
The pill is a novel
combination of bio-identical
estradiol and progesterone
approved for the treatment
of vasomotor symptoms
associated with menopause
in women with a uterus in a
once-daily soft gel capsule
taken orally.
TherapeuticsMD, a
women’s healthcare company
which makes the drug, expects
Bijuva to be available in the
US.
Sodium oxybate
for paediatric
cataplexy
Sodium oxybate (Xyrem)
has been approved to
treat cataplexy or excessive
daytime sleepiness (EDS)
in patients with narcolepsy
aged seven and older by
USFDA, announced Jazz
Pharmaceuticals.
Sodium oxybate, a central
nervous system depressant,
was previously only indicated
for use in adults.
The drug won the
approval for the treatment of
cataplexy or EDS in paediatric
patients with narcolepsy after
the findings of multisite Phase
2/3 EXPRESS study, which
enrolled patients seven to 17
years of age with narcolepsy
with cataplexy.
Study patients who were
sodium oxybate-naive at
entry underwent open-label
titration to reach a tolerable
and effective dose. All patients
then underwent a 2-week,
double-blind, randomisedwithdrawal
period and were
randomised to either remain
on sodium oxybate or receive
placebo.
The primary efficacy
endpoint was the change in a
weekly number of cataplexy
attacks from baseline to the
end of the double-blind
period. After this period,
patients entered an openlabel
safety period for up to
47 additional weeks.
The study found that
compared with sodium
oxybate-treated patients,
those who received the
placebo experienced a
statistically significant increase
in weekly cataplexy attacks.
In addition, patients in the
placebo group, during the
double blind treatment period,
experienced a statistically
significant worsening of EDS
vs patients who continued to
receive sodium oxybate.
EMA validates
quizartinib
for AML
D
aiichi Sankyo said the
European Medicines
Agency (EMA) granted
accelerated assessment for
quizartinib for the treatment
of adults with relapsed or
refractory acute myeloid
leukemia (AML) which is FLT3-
ITD positive.
Quizartinib is an oral
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