GlaxoSmithKline (LSE/NYSE: GSK) today announced that the US Food
and Drug Administration (FDA) has approved Nucala (mepolizumab) for
use in children as young as six years old who are living with
severe eosinophilic asthma. Nucala is the only targeted biologic to
be approved for the condition in the six to 11-year age group in
the US.
Dr Hal Barron, Chief Scientific Officer and President, R&D,
GSK, said: “Children with severe eosinophilic asthma currently have
limited treatment choices available to them. We believe this
important new indication for Nucala is a significant development
for these children and their families.”
Tonya Winders, CEO and President, Allergy and Asthma Network,
noted: “As a mother of children who suffer from asthma, I know
first-hand the huge impact it has on a family, from the constant
worry about your child being hospitalised, to practical issues like
arranging time off work to care for them. Having Nucala approved as
the first biologic for treating severe eosinophilic asthma in this
young age group represents a significant step forward for the
asthma community.”
The FDA approval is supported by an open-label study, conducted
in children aged six to 11 years and suffering from severe
eosinophilic asthma, that investigated Nucala’s pharmacokinetics,
pharmacodynamics and long-term safety. Evidence from adequate and
well-controlled trials in adults and adolescents also supported
approval in this age group. The 52-week long-term phase of the
study showed that the safety profile in paediatric patients aged
six to 11 years was similar to the known safety profile in patients
aged 12 years and older.
Dr Daniel Jackson, MD, Department of Pediatrics, University of
Wisconsin, added: “Severe eosinophilic asthma in children is a
complicated condition that can be extremely challenging to treat.
Nucala has made a difference for many adults and adolescents living
with severe asthma. This approval is an important development,
giving physicians like me a much-needed option to consider for our
paediatric patients.”
Nucala (100mg dose subcutaneous injection) was first approved in
2015 as an add-on maintenance treatment for patients with severe
eosinophilic asthma aged 12 years and older. This approval (40mg
dose subcutaneous injection) extends the current indication in the
US for Nucala to patients aged six to 11 years.
Nucala has been approved for use as an add-on treatment for
severe eosinophilic asthma in patients aged six years and older in
the EU since August 2018.
About Nucala (mepolizumab) First approved in 2015 for
severe eosinophilic asthma, mepolizumab is the first-in-class
monoclonal antibody that targets IL-5. It is believed to work by
preventing IL-5 from binding to its receptor on the surface of
eosinophils. Inhibiting IL-5 binding in this way reduces blood
eosinophils without completely depleting them.
Mepolizumab has been developed for the treatment of diseases
that are driven by inflammation caused by eosinophils. It has been
studied in over 3,000 patients in 21 clinical trials across a
number of eosinophilic indications and is the only biologic with
4.8 years of safety and efficacy data in severe eosinophilic asthma
(SEA). Mepolizumab has been approved (under the brand name Nucala)
in the US, Europe and in over 20 other markets, as an add-on
maintenance treatment for patients with severe eosinophilic asthma.
It is also the only anti-IL5 biologic therapy approved for
paediatric use from ages six to 17 in Europe in severe eosinophilic
asthma. In the US, Japan and Canada and a number of other markets,
it is approved as add-on maintenance treatment for patients with
EGPA. Mepolizumab is currently being investigated for severe
hypereosinophilic syndrome, nasal polyposis and COPD.
In the US, Nucala (100mg subcutaneous injection of mepolizumab)
is currently licensed as an add-on maintenance treatment for
patients with severe eosinophilic asthma aged 12 years and older.
This now extends to patients aged six to 11 years (40mg dose
subcutaneous injection). Nucala (300mg as three separate 100mg
subcutaneous injections of mepolizumab) is licensed for the
treatment of adult patients with eosinophilic granulomatosis with
polyangiitis (EGPA). Nucala is not approved for the relief of acute
bronchospasm or status asthmaticus. Full US Prescribing Information
is available at US Prescribing Information Nucala.
About severe asthma and eosinophilic inflammation Severe
asthma is defined as asthma which requires treatment with high dose
inhaled corticosteroids (ICS) plus a second controller (and/or
systemic corticosteroids) to prevent it from becoming
‘uncontrolled’ or which remains ‘uncontrolled’ despite this
therapy. Severe asthma patients are also often categorised by
long-term use of oral corticosteroids (OCS). In a sub-set of severe
asthma patients, the over-production of eosinophils (a type of
white blood cell) is known to cause inflammation in the lungs.
Interleukin-5 (IL-5) is the main promoter of eosinophil growth,
activation and survival and provides an essential signal for the
movement of eosinophils from the bone marrow into the lung. Studies
suggest that approximately 60% of patients with severe asthma have
eosinophilic airway inflammation.
GSK’s commitment to respiratory disease For 50 years, GSK
has led the way in developing medicines that advance the management
of asthma and COPD. From introducing the world’s first selective
short-acting beta agonist in 1969, to launching six treatments in
five years to create today’s industry-leading respiratory
portfolio, we continue to innovate so we can reach the right
patients, with the right treatment. Working together with the
healthcare community, we apply world-class science to discover and
understand the molecules that become the medicines of tomorrow. We
won’t stand still until the simple act of breathing is made easier
for everyone.
Serving paediatric patients We are committed to bringing
our specialty biologic medicines to paediatric patients who have
limited treatment options. We are currently progressing regulatory
reviews of treatments for children with severe eosinophilic asthma
and lupus, reinforcing our commitment to serving an unmet need with
these medicines that are proven to be effective in adults.
Important safety information for Nucala (mepolizumab) The
following is a summary of the safety information for Nucala. Please
consult the full Prescribing Information, including Patient
Information, at www.Nucala.com for all the safety information for
Nucala.
Nucala should not be administered to patients with a history of
hypersensitivity to mepolizumab or excipients in the
formulation.
Hypersensitivity reactions (e.g. anaphylaxis, angioedema,
bronchospasm, hypotension, urticaria, rash) have occurred after
administration of Nucala. Discontinue Nucala in the event of a
hypersensitivity reaction.
Do not use to treat acute bronchospasm or status
asthmaticus.
Herpes zoster infections have occurred in patients receiving
Nucala. Consider vaccination if medically appropriate.
Do not discontinue systemic or inhaled corticosteroids abruptly
upon initiation of therapy with Nucala. Decrease corticosteroids
gradually, if appropriate.
Treat patients with pre-existing helminth infections before
therapy with Nucala. If patients become infected while receiving
treatment with Nucala and do not respond to anti-helminth
treatment, discontinue Nucala until parasitic infection
resolves.
Adverse reactions Most common adverse reactions
(incidence ≥5%) in severe asthma clinical trials included headache,
injection site reaction, back pain, and fatigue. Injection site
reactions (e.g. pain, erythema, swelling, itching, burning
sensation) occurred in 8% of subjects treated with 100mg of Nucala
versus 3% treated with placebo.
In a clinical trial in patients with EGPA receiving 300 mg of
Nucala, no additional adverse reactions were identified to those
reported in severe asthma clinical trials. Injection site reactions
(e.g. pain, erythema, swelling) occurred in 15% of subjects treated
with 300 mg of Nucala versus 13% treated with placebo.
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Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or
projections made by GSK, including those made in this announcement,
are subject to risks and uncertainties that may cause actual
results to differ materially from those projected. Such factors
include, but are not limited to, those described under Item 3.D
Principal risks and uncertainties in the company's Annual Report on
Form 20-F for 2018.
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