FM OCTOBER 2018 ISSUE - digital edition

interval of 300 mg every four
weeks is also effective and
may be considered if the
patient is attack free for more
than six months.
The FDA approval of
lanadelumab was based
on data from four clinical
trials, including the HELP
(Hereditary Angioedema
Long-term Prophylaxis) Study,
the largest prevention study
conducted to date in HAE,
according to Shire.
In the Phase III HELP
study, lanadelumab reduced
the number of monthly HAE
attacks an average of 87%
(n=27) vs. placebo (n=41)
when administered at 300
mg every two weeks and 73%
(n=29) vs placebo (n=41)
when administered at 300 mg
every four weeks.
Lanadelumab has a halflife
of approximately two
weeks and is administered
as one subcutaneous selfinjection
every two weeks at
the recommended starting
dose.
Shire added lanadelumab
to its HAE portfolio with the
acquisition of Dyax Corp.
Oral RTK inhibitor
lenvatinib to
treat HCC
The EC has granted a
marketing authorization
for the oral receptor tyrosine
kinase (RTK) inhibitor
lenvatinib (Lenvima), as a
single agent for the firstline
treatment of adult
patients with advanced or
unresectable hepatocellular
carcinoma (HCC) who have
received no prior systemic
therapy.
Lenvatinib is the first
new, first-line treatment for
advanced or unresectable HCC
in a decade to show an overall
survival treatment effect by
statistical confirmation of noninferiority
against standard of
care, according to a joint press
statement by Eisai and Merck.
Lenvatinib's approval
was based on results from
REFLECT (Study 304), an
open-label, phase 3 trial
where the drug demonstrated
a treatment effect on
overall survival by statistical
confirmation of non-inferiority
when compared with the
standard of care, sorafenib, in
954 patients with previously
untreated unresectable HCC.
Lenvatinib also demonstrated
statistically significant
superiority and clinically
meaningful improvements in
progression-free survival and
objective response rate.
Currently, Lenvima is
marketed in Japan for
the treatment of HCC and
in the United States for
the treatment of first-line
unresectable HCC.
In March 2018, Eisai
and Merck entered into a
strategic collaboration for the
worldwide co-development
and co-commercialization of
Lenvima.
Loteprednol for
pain following
ocular surgery
The US FDA has approved
loteprednol etabonate
ophthalmic suspension 1%
(Inveltys) for the treatment of
post-operative inflammation
and pain following ocular
surgery. Inveltys is the first
twice-daily (BID) ocular
corticosteroid approved for
this indication.
All other ocular steroids
are approved for four-times-aday
dosing. The use of ocular
steroids post-surgery is to
achieve a rapid reduction of
inflammation and to promote
healing of the eye. Therefore,
ensuring close adherence
to the steroid regimen is a
critical factor for physicians in
the post-surgery care of the
patient and eventual overall
success of the procedure, Kala
Pharmaceuticals, Inc said.
Kala has initiated a third
Phase 3 clinical trial, STRIDE
3 (STRIDE - Short Term Relief
In Dry Eye), evaluating KPI-121
0.25% for the temporary relief
of the signs and symptoms of
dry eye disease.The company
expects to report top-line
results for STRIDE 3 in the
fourth quarter of 2019.
Kala also plans to submit
a New Drug Application (NDA)
for KPI-121 0.25% during
the second half of 2018. The
NDA will include data from
three clinical trials studying
approximately 2,000 patients,
including one Phase 2 trial and
two Phase 3 efficacy and safety
trials (STRIDE 1 and STRIDE 2),
the company said.
Oxervate, first rhNGF to treat
neurotrophic keratitis
The US FDA has approved
Oxervate (cenegerminbkbj
ophthalmic solution) to
treat neurotrophic keratitis
(NK), Dompé announced.
Neurotrophic keratitis,
characterised by corneal
scarring and vision loss, is a
rare orphan condition.
Oxervate represents the
first-ever topical biologic
medication approved in
ophthalmology, and is the
first ever application of
a human NGF as drug or
treatment, according to the
company.
Oxervate is based on
cenegermin-bkbj, a novel
recombinant human nerve
growth factor (rhNGF) that
is structurally identical to
the nerve growth factor
(NGF) protein that is made
in the human body, including
in the ocular tissues.
The endogenous protein
supports corneal integrity
though several mechanisms.
NGF acts directly on
corneal epithelial cells to
stimulate their growth and
survival. In addition, NGF
is known to bind receptors
on lacrimal glands to
promote tear production,
which may provide the
eye with lubrication and
natural protection from
pathogens and injury. The
protein also has been shown
experimentally to support
corneal innervation, which is
lost in neurotrophic keratitis.
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