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 10 September
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
Issued: 7 September 2018, London UK - LSE Announcement
GSK receives complete response letter from US FDA for use of
mepolizumab in COPD patients
GlaxoSmithKline plc (LSE/NYSE: GSK) today received a complete
response letter (CRL) from the US FDA regarding its application for
mepolizumab as an add-on treatment to inhaled
corticosteroid-based maintenance treatment for the reduction of
exacerbations in patients with chronic obstructive pulmonary
disease (COPD), guided by blood eosinophil counts.
The CRL states that more clinical data are required to support an
approval. GSK will work closely with the FDA to determine the
appropriate next steps for the supplementary biologics licence
application (sBLA).
About mepolizumab
First approved in 2015 for severe eosinophilic asthma, and also
licenced for EGPA in the US, 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 studied in over 3000 patients in 16 clinical trials across
a number of eosinophilic indications and is currently being
investigated for severe hypereosinophilic syndrome and nasal
polyposis, in addition to the sBLA filed for the treatment of
patients with COPD.
GSK in 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.
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.
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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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US Media enquiries:
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Karen Hagens
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+1 919 483 2863
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(North Carolina)
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Anna Padula
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+1 215 760 2928
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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
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.
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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.
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GlaxoSmithKline plc
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(Registrant)
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Date: September
10, 2018
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By: 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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