UNITED STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the
month of June, 2019
Commission
File Number 001-15170
GlaxoSmithKline plc
(Translation
of registrant's name into English)
980 Great West Road, Brentford, Middlesex, TW8
9GS
(Address
of principal executive office)
Indicate by check
mark whether the registrant files or will file annual reports under
cover of Form 20-F or Form 40-F.
Form
20-F . . . .X. . . . Form 40-F . . . . . . . .
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(1): ____
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(7): ____
Issued: Tuesday 4 June 2019, London UK - LSE
announcement
Nucala (mepolizumab) receives positive CHMP opinion for new
self-administration options
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 two
new methods for administering Nucala (mepolizumab) to patients with
severe eosinophilic asthma: a pre-filled pen and a pre-filled
safety syringe, to be taken once every four weeks.
If approved, the two new Nucala options will offer healthcare
professionals the choice of prescribing at-home administration for
appropriate patients. The original lyophilised powder version
remains available for administration in clinic by a healthcare
professional.
A CHMP positive opinion is one of the final steps before marketing
authorisation is granted by the European Commission.
Data supporting the recommendation
The CHMP opinion is supported by
positive
experience data from two open-label, single-arm, phase IIIa studies
(NCT03099096 & NCT03021304) evaluating the real-world use of
Nucala administered via the new options in clinic and at home by
patients with severe eosinophilic asthma, or their caregivers. Both
studies showed patients were able to successfully self-administer
treatment with both the pre-filled pen and pre-filled safety
syringe after appropriate training (89-95% and 100% respectively).
In addition, the majority of patients preferred at-home
administration options compared to in-clinic
administration.
A further open-label, parallel-group, single-dose pharmacokinetic
and pharmacodynamic study (NCT03014674), confirmed that the profile
of Nucala administered via the pre-filled safety syringe or
pre-filled pen was comparable to the originally approved
lyophilised formulation.
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. It is also the only anti IL-5 biologic therapy
approved for paediatric use from ages six to 17 in Europe in severe
eosinophilic asthma. In the US, Japan, Canada and a number of other
markets, it is also 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.
In Europe, Nucala is indicated as an add-on treatment for severe
refractory eosinophilic asthma in adults, adolescents and children
aged 6 years and older.
Nucala 100mg solution for injection in pre-filled pen and
pre-filled syringe are only appropriate for use by adults and
adolescents aged 12 years and over and are not indicated for
administration to children aged 6 to 11 years old. This population
should be treated with the lyophilised powder for solution for
injection.
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.
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. 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 symptoms 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.
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.
Severe
allergic reactions (anaphylaxis) is a rare side effect (may affect
up to 1 in 1,000 people).
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:
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UK
Media enquiries:
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Simon
Steel
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+44 (0)
20 8047 5502
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(London)
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Tim
Foley
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+44 (0)
20 8047 5502
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(London)
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US
Media enquiries:
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Evan
Berland
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+1 215
751 5497
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(Philadelphia)
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Analyst/Investor
enquiries:
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Sarah
Elton-Farr
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+44 (0)
20 8047 5194
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(London)
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James
Dodwell
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+44 (0)
20 8047 2406
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(London)
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Danielle
Smith
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+44 (0)
20 8047 7562
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(London)
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Jeff
McLaughlin
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+1 215
751 7002
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(Philadelphia)
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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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Registered in England & Wales:
No. 3888792
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Registered Office:
980 Great West Road
Brentford, Middlesex
TW8 9GS
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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.
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GlaxoSmithKline plc
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(Registrant)
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Date: June
04, 2019
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By:/s/ VICTORIA
WHYTE
--------------------------
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Victoria Whyte
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Authorised
Signatory for and on
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behalf
of GlaxoSmithKline plc
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