Blueprint
FORM 6-K
SECURITIES AND EXCHANGE COMMISSION
Washington D.C. 20549
Report of Foreign Issuer
Pursuant to Rule 13a-16 or 15d-16 of
the Securities Exchange Act of 1934
For
period ending 30 August
2018
GlaxoSmithKline plc
(Name
of registrant)
980 Great West Road, Brentford, Middlesex, TW8 9GS
(Address
of principal executive offices)
Indicate
by check mark whether the registrant files or
will
file annual reports under cover Form 20-F or Form 40-F
Form
20-F x Form 40-F
--
Indicate
by check mark whether the registrant by furnishing the
information
contained in this Form is also thereby furnishing the
information
to the Commission pursuant to Rule 12g3-2(b) under the
Securities
Exchange Act of 1934.
Yes
No x
30 August 2018, London, UK - LSE Announcement
European Commission approves Nucala (mepolizumab) for the treatment
of children with severe asthma
First anti-IL-5 biologic treatment for paediatric patients with
severe eosinophilic asthma in Europe
GlaxoSmithKline (LSE/NYSE: GSK) today announced that the European
Commission has granted marketing authorisation for Nucala
(mepolizumab) as an add-on treatment for severe refractory
eosinophilic asthma in paediatric patients aged six up to 17 years.
As a result of this licence extension Nucala is now approved for
use for severe refractory eosinophilic asthma in both adult and
paediatric patients in the 31 European countries covered by the
European Medicines Agency (EMA).
Dr Hal Barron, Chief Scientific
Officer and President, Pharmaceuticals R&D,
GlaxoSmithKline, said: "Asthma is the most common chronic
disease in
children. The availability of Nucala as
the first targeted treatment
available for young children with severe asthma, will
help provide asthma control for these children and reassurance to
their parents."
Nucala is the first and
only approved biologic therapy for paediatric patients with severe
asthma that targets interleukin-5 (IL-5), which plays an important
role in regulating the function of eosinophils.
There is a high unmet need in this population as the severity of
disease is greater among children and adolescents than adults, and
they are at greater risk of fatal or near-fatal events. Children
are also in need of new treatment options as they currently have
very limited options for severe asthma. In addition, long-term use
of the current standard of care, oral corticosteroids, is
associated with many of the adverse events observed in adults, with
the additional burden of impaired growth in children.
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.
For more information please see GSK's infographic
about severe asthma and role of eosinophils.
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.
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 16 clinical trials across a
number of eosinophilic indications and 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 and is the leading biologic in this indication.
In the US, Japan and Canada, it is approved as add-on maintenance
treatment for patients with eosinophilic granulomatosis with
polyangiitis (EGPA). Mepolizumab is currently being
investigated for severe hypereosinophilic syndrome, nasal polyposis
and COPD.
This marketing authorisation is based on a partial data
extrapolation approach which was agreed with the paediatrics
committee (PDCO) of the EMA. With this approach, efficacy and
safety data from the Phase III studies included in the mepolizumab
severe asthma development programme for patients 12 and over were
extrapolated to children. This approach was supported by the
adolescent data included in the Phase III severe asthma studies and
a PK/PD study in children 6-11 years old with severe eosinophilic
asthma. The agreement of this approach is based on an overlap in
the clinical presentation of both adult and paediatric severe
eosinophilic asthma, consistency in therapeutic approach,
consistency of mepolizumab mechanism of action, and relevance of
the clinical endpoints for both efficacy and safety. Additional PK,
PD and safety data in children under 18 years old in other
indications were also included in the data package, and the safety
profile in paediatric patients aged six up to 12 years is similar
to the safety profile in patients aged 12 years and
older.
GSK's commitment to respiratory disease
GSK has led the way in developing innovative medicines to advance
the management of asthma and COPD for nearly 50 years. Over the
last five years we have launched six innovative medicines
responding to continued unmet patient need, despite existing
therapies. This is an industry leading portfolio in breadth, depth
and innovation, developed to reach the right patients, with the
right treatment.
Important Safety Information for Nucala (mepolizumab)
The following Important Safety Information is based on a summary of
the European Summary of Product Characteristics and Prescribing
Information for Nucala in patients 18 and
over. For
the full EU Summary of Product Characteristics for Nucala, please
visit: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003860/human_med_001933.jsp&mid=WC0b01ac058001d124.
Prior to the label for paediatric use being posted online, a copy
of the label may be requested from one of the GSK Media or Investor
Relations contacts listed in the "GSK Enquiries" section at the end
of this document.
Nucala is contraindicated in patients with hypersensitivity to
mepolizumab or to any of the excipients.
Nucala should not be used to treat acute asthma
exacerbations.
Asthma-related adverse events or exacerbations may occur during
treatment. Patients should be instructed to seek medical advice if
their asthma remains uncontrolled or worsens after initiation of
treatment.
Abrupt discontinuation of corticosteroids after initiation of
Nucala therapy is not recommended. Reduction in corticosteroid
doses, if required, should be gradual and performed under the
supervision of a physician.
Acute and delayed systemic reactions, including hypersensitivity
reactions (e.g. anaphylaxis, urticaria, angioedema, rash,
bronchospasm, hypotension), have occurred following administration
of Nucala. These reactions generally occur within hours of
administration, but in some instances have a delayed onset (i.e.,
typically within several days). These reactions may occur for the
first time after a long duration of treatment.
Herpes zoster has occurred in subjects receiving Nucala in
controlled clinical trials. Consider vaccination if medically
appropriate.
Eosinophils may be involved in the immunological response to some
helminth infections. Patients with pre-existing helminth infections
should be treated for the helminth infection before starting
therapy with Nucala. If patients become infected whilst receiving
treatment with Nucala and do not respond to anti-helminth
treatment, temporary discontinuation of therapy should be
considered.
In clinical studies in subjects with severe refractory eosinophilic
asthma, the most commonly reported adverse reactions during
treatment were headache, injection site reactions and back
pain. Headache was considered very common, occurring with a
frequency of ≥1/10. Common adverse drug reactions
(≥1/100 to <1/10) included: lower respiratory tract
infection, urinary tract infection, pharyngitis, hypersensitivity
reactions (systemic, allergic), nasal congestion, upper abdominal
pain, eczema, back pain, administration-related reaction (systemic,
non-allergic), local injection site reactions, and
pyrexia.
Injection site reactions (e.g., pain, erythema, swelling, itching,
and burning sensation) occurred at a rate of 8% in subjects treated
with Nucala compared with 3% in subjects treated with
placebo.
GSK -
a science-led global healthcare company with a special purpose: to
help people do more, feel better, live longer. For further
information please visit www.gsk.com
Trademarks are owned by or licensed to the GSK group of
companies.
|
GSK enquiries:
|
|
|
|
|
|
UK Media enquiries:
|
Simon Steel
|
+44 (0) 20 8047 5502
|
(London)
|
|
|
US Media enquiries:
|
Sarah Spencer
|
+1 215 751 3335
|
(Philadelphia)
|
|
|
|
Karen Hagens
|
+1 919 483 2863
|
(North Carolina)
|
|
|
|
|
|
|
|
|
Analyst/Investor enquiries:
|
Sarah Elton-Farr
|
+44 (0) 208 047 5194
|
(London)
|
|
|
|
Danielle Smith
|
+44 (0) 20 8047 7562
|
(London)
|
|
|
|
James Dodwell
|
+44 (0) 20 8047 2406
|
(London)
|
|
|
|
Jeff McLaughlin
|
+1 215 751 7002
|
(Philadelphia)
|
|
|
Cautionary statement regarding forward-looking
statementsGSK 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
2017.
|
|
Registered in England & Wales:
No. 3888792
|
|
|
|
|
|
Registered Office:
980 Great West Road
Brentford, Middlesex
TW8 9GS
|
|
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorised.
|
|
GlaxoSmithKline plc
|
|
|
(Registrant)
|
|
|
|
|
Date: August
30, 2018
|
|
|
|
|
|
|
By: VICTORIA
WHYTE
--------------------------
|
|
|
|
|
|
Victoria Whyte
|
|
|
Authorised
Signatory for and on
|
|
|
behalf
of GlaxoSmithKline plc
|