April 2019 digital edition

drug approvals
Solriamfetol to treat
narcolepsy, OSA
The US FDA has approved
solriamfetol (Sunosi) to
treat excessive sleepiness
in adult patients with
narcolepsy or obstructive
sleep apnea (OSA), Jazz
Pharmaceuticals Plc said.
Solriamfetol is a dualacting
dopamine and
norepinephrine reuptake
inhibitor (DNRI) indicated
to improve wakefulness in
adults living with excessive
daytime sleepiness due to
narcolepsy or OSA.
The drug is expected to
be commercially available
in the US following the
final scheduling decision
by the Drug Enforcement
Administration (DEA).
The FDA’s approval of
solriamfetol is based on
data from the Treatment
of Obstructive sleep apnea
and Narcolepsy Excessive
Sleepiness (TONES) phase 3
clinical programmes, which
included four randomized
placebo-controlled studies
that demonstrated the
superiority of the drug
relative to placebo.
The approval comes as
Jazz is trying to reduce its
reliance on its blockbuster
narcolepsy drug, Xyrem,
whose patents were
declared invalid by a US
appeals court in July.
Atezolizumab
plus chemo for
extensive SCLC
Roche said the USFDA
approved atezolizumab
(Tecentriq), in combination
with carboplatin and
etoposide, for the first-line
treatment of adults with
extensive-stage small cell lung
cancer (ES-SCLC).
This approval is based
on results from the phase
III IMpower133 study, which
showed that atezolizumab
in combination with
chemotherapy helped people
live significantly longer
compared to chemotherapy
alone.
The atezolizumab-based
combination also significantly
reduced the risk of disease
worsening or death compared
to chemotherapy alone. Safety
for the atezolizumab and
chemotherapy combination
appeared consistent with
the known safety profile of
atezolizumab.
In the US, atezolizumab
is approved in combination
with bevacizumab, paclitaxel
and carboplatin, for the firstline
treatment of adults with
metastatic non-squamous
NSCLC with no EGFR or ALK
genomic tumour aberrations.
In Europe, the
atezolizumab and
bevacizumab combination
is approved for the initial
treatment of people with
metastatic non-squamous
NSCLC, including people with
EGFR mutant or ALK genomic
tumour aberrations after the
failure of appropriate targeted
therapies.
Atezolizumab is also
approved by the FDA to treat
adults with metastatic NSCLC
who have disease progression
during or following platinumcontaining
chemotherapy.
IMpower133 is a phase
III, multicentre, doubleblinded,
randomised placebocontrolled
study evaluating
the efficacy and safety of
atezolizumab in combination
with chemotherapy
vs. chemotherapy vs.
chemotherapy alone in
chemotherapy-naïve adults
with ES-SCLC.
Atezolizumab is a
monoclonal antibody
designed to bind with
a protein called PD-L1
expressed on tumour cells
and tumour-infiltrating
immune cells, blocking its
38 / FUTURE MEDICINE / April 2019