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 27 July
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
27 July 2018, London, UK - LSE
Announcement
CHMP recommend Nucala (mepolizumab) for the treatment of severe
eosinophilic asthma paediatric patients in Europe
GlaxoSmithKline (LSE/NYSE: GSK) today announced that the European
Medicines Agency's (EMA) Committee for Medicinal Products for Human
Use (CHMP) has issued a positive opinion recommending Nucala
(mepolizumab) as an add-on treatment for severe refractory
eosinophilic asthma in paediatric patients aged six up to 17 years.
If approved it would be the first targeted biologic therapy for the
treatment of severe eosinophilic asthma in paediatric patients in
Europe.
Dr Hal Barron, Chief Scientific Officer and President, R&D GSK
said: "Ensuring our medicines have the broadest possible label is
very important, as it allows us to help the greatest number of
patients who may benefit. If approved Nucala could provide an
additional option for younger patients in Europe who still struggle
to control their asthma despite taking inhaled steroids and other
controller medications. These are patients who are at high risk of
asthma attacks, which can be a very frightening experience for
anyone, especially young children."
Asthma is the commonest chronic disease in childhood and severe
asthma that is poorly responsive to current standard of care asthma
treatments has been reported in approximately 4.5% of children with
asthma.1
A CHMP positive opinion is one of the final steps before marketing
authorisation is granted by the European Commission.
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 that
can affect the airways, limiting breathing and increasing the
frequency of asthma attacks. 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.
About Nucala (mepolizumab)
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 white blood cells called 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
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).
This paediatric licence application is supported by a partial
extrapolation approach agreed with the EU Paediatric Committee of
the European Medicines Agency which utilised the efficacy and
safety data available in paediatric patients and its
well-documented positive benefit to risk profile in adult patients.
Existing data was used from adolescent participants in the
mepolizumab severe asthma pivotal programme in addition to new data
from children in the pharmacokinetic (PK)/ pharmacodynamic (PD)
study 200363. Part A, completed in children 6-11 years old with
severe eosinophilic asthma, collected uncontrolled safety and
limited efficacy data and showed that subcutaneous PK data in
children 6 to 11 years is consistent with adults after adjustment
for bodyweight and bioavailability and that mepolizumab blood
eosinophil count reduction in adults is predictive of the blood
eosinophil count reduction in paediatric patients. The safety
profile of mepolizumab in children and adolescents with severe
asthma appears similar to that of adolescents and adults from the
Phase III placebo controlled severe eosinophilic asthma studies. No
new safety concerns were identified for paediatrics when compared
with the overall adolescent and adult data from the Phase III
placebo controlled severe eosinophilic asthma studies.
The adult application was supported with data from the mepolizumab
phase II/III clinical development programme, which involved nine
studies and a total of 915 patients with severe refractory
eosinophilic asthma. Patients received either a subcutaneous or an
intravenous dose of mepolizumab during clinical studies of 24 to 52
weeks duration. Three key clinical trials - DREAM (MEA112997),
MENSA (MEA115588) and SIRIUS (MEA115575) - have established the
efficacy and safety profile of Nucala for severe refractory
eosinophilic asthma patients.
The European Marketing Authorisation Application for Nucala in
patients over 18 was submitted to the EMA on 21 November 2014 and
was approved on 2 December 2015.
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
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. Please
consult the full Summary of Product Characteristics and Prescribing
Information for all the safety information for Nucala.
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.
1. ERS
White Book. https://www.erswhitebook.org/files/public/Chapters/11_childhood_asthma.pdf
(last accessed July
2018)
|
GSK enquiries:
|
|
|
|
|
|
UK Media enquiries:
|
Simon Steel
|
+44 (0) 20 8047 5502
|
(London)
|
|
|
US Media enquiries:
|
Sarah Alspach
|
+1 202 715 1048
|
(Washington, DC)
|
|
|
|
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
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 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: July
27, 2018
|
|
|
|
|
|
|
By: VICTORIA
WHYTE
--------------------------
|
|
|
|
|
|
Victoria Whyte
|
|
|
Authorised
Signatory for and on
|
|
|
behalf
of GlaxoSmithKline plc
|