FM AUGUST 2018 ISSUE1 - digital edition

drug approvals
Tofacitinib oral pill
for ulcerative colitis
T
he U.S. Food and Drug
Administration expanded the
approval of tofacitinib (Xeljanz) to
include adults with moderately to
severely active ulcerative colitis. Xeljanz
is the first oral medication approved for
chronic use in this indication.
Tofacitinib contains JAKs (Janus Kinases),
which transfer signals from cytokine to
regulate immune cell function. Within
the signaling pathway, JAKs also activate
phosphorylate and Signal Transducers and
Activators of Transcription (STATs), which
regulate intracellular activity.
The efficacy of tofacitinib for the
treatment of this inflammatory bowel
disease was demonstrated in three
controlled clinical trials. This included two
8-week placebo-controlled trials that
demonstrated that 10 mg of tofacitinib
given twice daily induces remission in 17
to 18 percent of patients by week eight.
Tofacitinib, made by Pfizer Labs,
was previously approved in 2012 for
rheumatoid arthritis and in 2017 for
psoriatic arthritis.
Andexanet Alfa
for reversal of
anticlotting effects
A
ndexanet alfa (Andexxa) has been
granted approval by the USFDA as
an agent for reversing the anticoagulant
effects of Factor Xa inhibitors.
Andexanet alfa is the first antidote
indicated for the patients treated with
rivaroxaban (Xarelto) and apixaban
(Eliquis), the inhibitors of Factor Xa,
announced by Andexxa’s manufacturer
Portola Pharmaceuticals.
Andexanet's approval is supported
by data from two Phase 3 ANNEXA
studies published in The New England
Journal of Medicine, which evaluated
the safety and efficacy of Andexxa in
reversing the anticoagulant activity of
the Factor Xa inhibitors rivaroxaban and
apixaban in healthy volunteers. Results
demonstrated that Andexxa rapidly
and significantly reversed anti-Factor
Xa activity.
Fast Track desig
for chikungunya
vaccine
T
he US FDA granted Fast Track
designation for a candidate vaccine
against the disease caused by
chikungunya virus, announced PaxVax,
the developer of the vaccine.
The vaccine was licensed from the
National Institute of Allergy and Infectious
Diseases (NIAID) at National Institutes of
Health (NIH).
The Phase 2b study of the virus-like
particle (VLP) vaccine is in the process of
enrolling 400 subjects to evaluate multiple
dosing regimens. PaxVax expects the
results in early 2019.
VLP vaccines are multi-protein structures
that mimic the organization and
conformation of naturally occurring
viruses, but lack the viral genome.
They are non-infectious. Additionally,
the chikungunya VLP vaccine
maintains natural epitopes to mimic
natural infection.
Spreads through mosquito bites, the virus
can often cause large outbreaks. In 2016
there were approximately 60,000 cases of
chikungunya across India.
Fostamatinib
tablets for ITP
F
ostamatinib disodium hexahydrate
(Tavalisse) has been granted
approval by US FDA for the treatment of
thrombocytopenia in adults with chronic
immune thrombocytopenia (ITP).
Fostamatinib, an oral spleen tyrosine
kinase (SYK) inhibitor, works by targeting
the underlying autoimmune cause of the
disease by blocking platelet destruction.
Its major metabolite, R406, inhibits signal
30 / FUTURE MEDICINE / AUGUST 2018