GlaxoSmithKline PLC Regulatory submissions for mepolizumab (2164W)
05 November 2014 - 10:22PM
UK Regulatory
TIDMGSK
RNS Number : 2164W
GlaxoSmithKline PLC
05 November 2014
Issued: Wednesday 5 November 2014, London UK - LSE
Announcement
GSK announces regulatory submissions for mepolizumab in severe
eosinophilic asthma
- Submissions filed in USA and Europe for anti-IL5 monoclonal
antibody
GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that it has
filed regulatory submissions in the USA and Europe for mepolizumab
for approval as a maintenance treatment for patients with severe
eosinophilic asthma, identified by a blood eosinophil count of at
least 150 cells per microlitre at the start of treatment or 300
cells per microlitre in the past 12 months. The submissions
comprise:
-- A Biologics Licence Application to the US Food and Drug
Administration as an add-on maintenance treatment for severe
eosinophilic asthma in patients aged 12 years and older with a
history of exacerbations.
-- A Marketing Authorisation Application to the European
Medicines Agency as an add-on treatment for severe eosinophilic
asthma in adult patients with a history of exacerbations and/or
dependency on systemic corticosteroids.
Mepolizumab is a monoclonal antibody that is delivered in a
100mg dose via subcutaneous injection every four weeks. The
regulatory submissions in the USA and Europe are based on studies
of patients with severe asthma and include the phase III MENSA(1)
and SIRIUS(2) studies published in the New England Journal of
Medicine in September 2014 as well as the earlier phase IIb/III
DREAM(3) study published in the Lancet in 2012. Both the MENSA and
SIRIUS studies evaluated patients with bloodeosinophils of either
150 or more cells per microlitre at initiation of treatment or 300
or more cells per microlitre in the previous 12 months.
Dave Allen, Head, Respiratory Therapy Area Unit, R&D, said,
"Severe asthma can have serious health consequences and for
patients with elevated eosinophil levels whose disease remains
uncontrolled despite taking medication, there are few treatment
options. With the regulatory filings announced today, we are taking
a further step towards making mepolizumab available for this
difficult-to-treat group."
Regulatory filings in other countries are planned during the
course of 2014 and 2015. Mepolizumab is not currently approved for
use anywhere in the world.
About asthma
Currently the World Health Organization estimates that as many
as 235 million people live with asthma worldwide. For many of these
patients use of inhaled therapies can provide adequate control of
their symptoms however there are as many as 10 percent who live
with severe asthma and cannot achieve control with inhaled
therapies.
The role of eosinophils in asthma
Although asthma is a heterogeneous disease it is often
characterised by an accumulation of eosinophils (white blood cells)
in lung tissues and, in general, eosinophil levels correlate with
severity and frequency of exacerbations. 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 mepolizumab
Mepolizumab is an investigational humanised IgG(1) monoclonal
antibody specific for IL-5, which binds to IL-5, stopping it from
binding to its receptor on the surface of eosinophils. Inhibiting
IL-5 binding in this way reduces blood, tissue and sputum
eosinophil levels. Mepolizumab is also being investigated in
eosinophilic COPD and Eosinophilic Granulomatosis with Polyangiitis
(EGPA).
V A Whyte
Company Secretary
5 November 2014
GSK - one of the world's leading research-based pharmaceutical
and healthcare companies - is committed to improving the quality of
human life by enabling people to do more, feel better and live
longer. For further information please visit www.gsk.com.
GSK enquiries:
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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 'Risk factors' in the company's Annual Report on Form 20-F
for 2013.
References
(1) N Engl J Med 2014;371: 1198-1207, Ortega HG et al
(2) N Engl J Med 2014; 371: 1189-1197 Bel EH et al
(3) Lancet 2012; 380: 651-59, Pavord I et al
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