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of bleeding when dosed every<br />
four weeks.<br />
Emicizumab, was approved<br />
by the US FDA for routine<br />
prophylaxis to prevent or<br />
reduce the frequency of<br />
bleeding episodes in adults<br />
and children, ages newborn<br />
and older, with haemophilia A<br />
without factor VIII inhibitors,<br />
following Priority Review, in<br />
2018.<br />
Guselkumab<br />
injector for<br />
psoriasis in US<br />
Guselkumab (Tremfya),<br />
a single-dose, patientcontrolled<br />
injector, has been<br />
approved for adults with<br />
moderate-to-severe plaque<br />
psoriasis by US FDA.<br />
Guselkumab is a human<br />
anti-IL-23 monoclonal antibody<br />
developed by Janssen utilizing<br />
MorphoSys’s proprietary HuCAL<br />
antibody technology.<br />
In phase 3, multicentre<br />
and randomized ORION<br />
study, patient experience with<br />
the one-press injector was<br />
assessed through a validated<br />
Self-Injection Assessment<br />
Questionnaire (SIAQ), which<br />
evaluated patient experience.<br />
The efficacy and safety<br />
of guselkumab administered<br />
with one-press in patients with<br />
moderate to severe plaque<br />
psoriasis were also evaluated<br />
in the double-blind, placebocontrolled<br />
ORION study.<br />
EMA conditional<br />
okay for<br />
andexanet alfa<br />
EMA’s human medicines<br />
committee (CHMP) has<br />
recommended for granting<br />
a conditional marketing<br />
authorisation for andexanet<br />
alfa (Ondexxya) to be used as<br />
an antidote for adult patients<br />
taking the anticoagulant<br />
medicines apixaban or<br />
rivaroxaban, when reversal of<br />
their action is needed due to<br />
life-threatening or uncontrolled<br />
bleeding.<br />
Apixaban and rivaroxaban<br />
belong to a newer class of<br />
anticoagulants called factor Xa<br />
(FXa) inhibitors, which work by<br />
blocking the action of activated<br />
factor X, a substance in the<br />
blood that has a key role in<br />
making it clot.<br />
However, because<br />
anticoagulants stop the blood<br />
from clotting normally, patients<br />
taking them can be at risk<br />
of serious and uncontrolled<br />
bleeding, especially in<br />
emergency situations. Until<br />
now, there has been no<br />
specific antidote that could<br />
prevent the anticoagulant<br />
effect of apixaban or<br />
rivaroxaban once they have<br />
been given.<br />
Andexanet alfa is a<br />
recombinant protein that<br />
acts as a decoy for the direct<br />
oral FXa inhibitors apixaban<br />
and rivaroxaban in the blood.<br />
As a result, andexanet alfa<br />
neutralises the anticoagulant<br />
effect of these inhibitors<br />
The effects of the therapy<br />
were studied in 352 patients<br />
for safety and 167 patients<br />
for efficacy. Clinical efficacy<br />
is based upon reversal of<br />
anti-fXa-activity in healthy<br />
volunteers and interim results<br />
of study in patients with lifethreatening<br />
bleeding.<br />
Ondexxya enabled the<br />
reversal of the apixaban and<br />
rivaroxaban anticoagulant<br />
effect within 2 minutes of its<br />
administration.<br />
Priority review for dupilumab to treat severe rhinosinusitis<br />
Dupilumab (Dupixent) has been<br />
accepted for a priority review by<br />
US FDA as an add-on maintenance<br />
treatment for adults with inadequately<br />
controlled severe chronic rhinosinusitis<br />
with nasal polyps (CRSwNP).<br />
Patients with severe CRSwNP<br />
often experience recurrence despite<br />
previous treatment with surgery and/<br />
or systemic corticosteroids.<br />
Currently, there are no FDAapproved<br />
biologic medicines to treat<br />
CRSwNP, a chronic disease of the<br />
upper airway predominantly driven by<br />
type 2 inflammation and characterized<br />
by polyps that obstruct the sinuses<br />
and nasal passages.<br />
Regeneron and Sanofi presented<br />
data from two pivotal Phase 3 trials<br />
evaluating the efficacy and safety<br />
of dupilumab when combined with<br />
standard-of-care corticosteroid nasal<br />
spray in patients with recurring severe<br />
CRSwNP despite previous treatment<br />
with surgery and/or systemic<br />
corticosteroids.<br />
Dupilumab is a human monoclonal<br />
antibody specifically designed to<br />
inhibit signalling of interleukin-4 and<br />
interleukin-13. The findings from<br />
these trials, as well as from prior<br />
trials in atopic dermatitis and asthma,<br />
demonstrate that both IL-4 and IL-13<br />
are two key proteins that play a central<br />
role in type 2 inflammation, which<br />
seems to underlie CRSwNP as well as<br />
several other allergic diseases.<br />
In the US, dupilumab is approved<br />
for treatment of adult patients with<br />
moderate-to-severe atopic dermatitis<br />
(eczema) that is not well controlled<br />
with prescription therapies used on<br />
the skin, or who cannot use topical<br />
therapies.<br />
42 / FUTURE MEDICINE / <strong>April</strong> <strong>2019</strong>
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