TIDMGSK
RNS Number : 4767J
GlaxoSmithKline PLC
28 June 2017
Issued: Wednesday 28 June 2017, London, UK
GSK announces US regulatory submission for mepolizumab in
Eosinophilic Granulomatosis with Polyangiitis (EGPA)
GlaxoSmithKline plc (LSE/NYSE: GSK) today announced the
submission of a supplemental Biologics License Application (sBLA)
to the United States Food and Drug Administration (FDA), seeking
approval of mepolizumab, an interleukin-5 (IL-5) antagonist, as an
add-on therapy to corticosteroids for the treatment of adult
patients with Eosinophilic Granulomatosis with Polyangiitis (EGPA).
EGPA is a rare disease, characterised by widespread inflammation in
the walls of small blood vessels (vasculitis) which may lead to
tissue and organ damage. The disease may affect multiple organ
systems and be associated with symptoms of fatigue, muscle and
joint pain and weight loss.
Birgitte Volck, head of rare diseases R&D at GSK, said: "The
symptoms associated with EGPA are diverse and patients often
experience delay in diagnosis. The burden of disease may be severe,
preventing patients from carrying out everyday activities and
recurrent relapses place them at risk of permanent tissue and organ
damage. If approved, mepolizumab will be the first treatment in the
US indicated for EGPA and has the potential to offer healthcare
professionals and patients a new treatment option to help improve
symptoms and disease control."
The regulatory submission is based on results from a pivotal,
52-week Phase III study which evaluated the efficacy and safety of
mepolizumab vs placebo as an add-on therapy to standard of care in
patients with relapsing and/or refractory EGPA.
Regulatory filings in other countries are planned during the
course of 2017 and 2018. Mepolizumab is not approved anywhere in
the world for EGPA.
About EGPA (previously known as Churg-Strauss Syndrome)
Eosinophilic Granulomatosis with Polyangiitis (EGPA) is a rare
disease that causes inflammation in the walls of small blood
vessels (or vasculitis). The global incidence is generally reported
to be in the range 1-4 per million, with an estimated prevalence of
approximately 14-45 per million. The mean age of diagnosis is 48
years and the disease can be life-threatening for some
patients.
In EGPA, patients usually develop asthma initially, before the
vasculitis extends to inflammation in the walls of small blood
vessels that supply tissues in the lungs, sinuses, skin, nerves and
other organs. EGPA can result in damage to multiple organs in the
body and the symptoms common to most include extreme fatigue,
weight loss, muscle and joint pain, sinonasal symptoms and
breathlessness, all of which affect patients' ability to carry out
everyday activities without difficulty.
The current approach to disease management is primarily based on
reduction of active inflammation and suppression of the immune
response through the use of corticosteroid therapy and concomitant
immunosuppressive therapy (e.g., methotrexate, azathioprine,
mycophenolate mofetil) and/or cytotoxic agents (e.g.,
cyclophosphamide). Although the use of these treatments can be
effective for establishing remission, patients remain vulnerable to
either the complications of the long-term use of these therapies,
or to the risk of relapse, particularly if the dose of
corticosteroid is reduced.
About mepolizumab
Mepolizumab is a targeted anti-IL-5 monoclonal antibody.
Mepolizumab binds to the signalling protein IL-5, preventing it
from binding to its receptor on the surface of white blood cells
called eosinophils. Inhibiting IL-5 binding in this manner reduces
blood, tissue and sputum eosinophil levels.
Eosinophils are believed to play a role in protecting the body
against infection. In some people, increased eosinophil levels can
lead to inflammation and play a role in the development of some
inflammatory diseases.
Mepolizumab has been developed for the treatment of diseases
that are driven by inflammation caused by eosinophils. Mepolizumab
is approved for use in the US, under the brand name Nucala, as the
first-in-class add-on maintenance treatment for patients with
severe asthma aged 12 years and older, and with an eosinophilic
phenotype. Nucala has also been approved for severe eosinophilic
asthma in the EU, Japan and a number of other countries worldwide
although the details of the indications may vary. Trademarks are
owned by or licensed to the GSK group of companies.
Mepolizumab is not approved anywhere in the world for EGPA.
Mepolizumab is also being investigated in chronic obstructive
pulmonary disease (in phase III), eosinophilic granulomatosis with
polyangiitis (EPGA, also referred to as Churg-Strauss syndrome, in
phase III), severe hypereosinophilic syndrome (in phase III), and
severe atopic dermatitis (phase II).
Important Safety Information for Nucala in Severe Asthma with an
Eosinophilic Phenotype (based on US Prescribing Information)
Please consult the full Prescribing Information for all the
labelled safety information for Nucala.
CONTRAINDICATIONS
Nucala should not be administered to patients with a history of
hypersensitivity to mepolizumab or excipients in the
formulation.
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions
Hypersensitivity reactions (e.g. anaphylaxis, angioedema,
bronchospasm, hypotension, urticaria, rash) have occurred following
administration of Nucala. These reactions generally occur within
hours of administration but in some instances can have a delayed
onset (i.e. days). In the event of a hypersensitivity reaction,
Nucala should be discontinued.
Acute Asthma Symptoms or Deteriorating Disease
Nucala should not be used to treat acute asthma symptoms, acute
exacerbations, or acute bronchospasm.
Opportunistic Infections: Herpes Zoster
In controlled clinical trials, 2 serious adverse reactions of
herpes zoster occurred in subjects treated with Nucala compared to
none in placebo. Consider varicella vaccination if medically
appropriate prior to starting therapy with Nucala.
Reduction of Corticosteroid Dosage
Do not discontinue systemic or inhaled corticosteroids (ICS)
abruptly upon initiation of therapy with Nucala. Decreases in
corticosteroid doses, if appropriate, should be gradual and under
the direct supervision of a physician. Reduction in corticosteroid
dose may be associated with systemic withdrawal symptoms and/or
unmask conditions previously suppressed by systemic corticosteroid
therapy.
Parasitic (Helminth) Infection
It is unknown if Nucala will influence a patient's response
against parasites. Treat patients with pre-existing helminth
infections before initiating therapy with Nucala. If patients
become infected while receiving treatment with Nucala and do not
respond to anti-helminth treatment, discontinue treatment with
Nucala until infection resolves.
ADVERSE REACTIONS
The most common adverse reactions (>=3% and more common than
placebo) reported in the first 24 weeks of two clinical trials with
Nucala (and placebo) were: headache, 19% (18%); injection site
reaction, 8% (3%); back pain, 5% (4%); fatigue, 5% (4%); influenza,
3% (2%); urinary tract infection 3% (2%); abdominal pain upper, 3%
(2%); pruritus, 3% (2%); eczema, 3% (<1%); and muscle spasm, 3%
(<1%).
Systemic Reactions, including Hypersensitivity Reactions: In 3
clinical trials, 3% of subjects who received Nucala experienced
systemic (allergic and nonallergic) reactions compared to 5% in the
placebo group. Systemic allergic/hypersensitivity reactions were
reported by 1% of subjects who received Nucala compared to 2% of
subjects in the placebo group. Manifestations included rash,
pruritus, headache, and myalgia. Systemic nonallergic reactions
were reported by 2% of subjects who received Nucala and 3% of
subjects in the placebo group. Manifestations included rash,
flushing, and myalgia. A majority of the systemic reactions were
experienced on the day of dosing. Reports of anaphylaxis have been
received postmarketing.
Injection site reactions (e.g. pain, erythema, swelling,
itching, burning sensation) occurred at a rate of 8% in subjects
treated with Nucala compared with 3% in subjects treated with
placebo.
USE IN SPECIFIC POPULATIONS
The data on pregnancy exposures from the clinical trials are
insufficient to inform on drug-associated risk. Monoclonal
antibodies, such as mepolizumab, are progressively transported
across the placenta in a linear fashion as pregnancy progresses;
therefore, potential effects on a foetus are likely to be greater
during the second and third trimesters of pregnancy.
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:
Fiona McMillan +44 (0) 20 (London)
8047 5502
David Daley +44 (0) 20 (London)
8047 5502
US Media enquiries: Anna Padula +1 215 751 (Philadelphia)
4271
Sarah Spencer +1 215 751 (Philadelphia)
3335
Analyst/Investor Sarah Elton-Farr +44 (0) 20 (London)
enquiries: 8047 5194
Tom Curry + 1 215 751 (Philadelphia)
5419
Gary Davies +44 (0) 20 (London)
8047 5503
James Dodwell +44 (0) 20 (London)
8047 2406
Jeff McLaughlin +1 215 751 (Philadelphia)
7002
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 2016.
Registered in England & Wales:
No. 3888792
Registered Office:
980 Great West Road
Brentford, Middlesex
TW8 9GS
This information is provided by RNS
The company news service from the London Stock Exchange
END
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