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 12 December
2017
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
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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:
Tuesday 12 December 2017, London UK
GSK achieves approval for Nucala (mepolizumab) for the treatment of
eosinophilic granulomatosis with polyangiitis (EGPA) for adults in
the US
First targeted treatment approved for this rare eosinophil-driven
disease, following FDA Priority Review
GlaxoSmithKline
plc (LSE/NYSE: GSK) today announced that the US Food and Drug
Administration (FDA) has approved Nucala (mepolizumab) as the first
targeted treatment for eosinophilic granulomatosis with
polyangiitis (EGPA), previously known as Churg-Strauss syndrome.
GSK submitted a supplemental Biologics License Application (sBLA)
for mepolizumab, an interleukin-5 (IL-5) antagonist, in June
2017.
Eric
Dube, Senior Vice President & Head, GSK Global Respiratory
Franchise, said: "Following physician and patient experience with
Nucala in severe eosinophilic asthma, we are thrilled that the FDA
has expanded the use of this medicine to patients with EGPA,
another eosinophil-driven disease, enabling GSK to make it
available to patients. This approval follows the positive results
of the largest prospective treatment study conducted in EGPA to
date, and now for the first time physicians have a targeted
treatment option for this debilitating condition." Mepolizumab is
not approved for the treatment of other eosinophilic conditions or
relief of acute bronchospasm or status asthmaticus.
The
approval for EGPA is based on results from the pivotal, 52-week,
Phase III MIRRA1 study, conducted as
a collaboration between GSK and the National Institute of Allergy
and Infectious Diseases, part of the US National Institutes of
Health.
The
MIRRA study evaluated the efficacy and safety of 300mg of
mepolizumab administered subcutaneously every four weeks versus
placebo as add-on therapy to standard of care (corticosteroids plus
or minus immunosuppressants) in 136 patients with relapsing and/or
refractory EGPA:
- both
co-primary endpoints (accrued time in remission and proportion of
patients achieving remission at both weeks 36 and 48) were
statistically significant in favour of mepolizumab
- all
six secondary endpoints (investigating relapse, remission, and
corticosteroid use) were met in favour of mepolizumab
- the
percentage of patients experiencing on-treatment adverse events was
comparable between the two treatment groups (97% mepolizumab versus
94% placebo). Injection site reactions (e.g., pain, erythema,
swelling) occurred at a rate of 15% in patients receiving
mepolizumab compared with 13% in patients receiving placebo.
Eighteen percent of
patients receiving mepolizumab reported serious adverse events
compared with 26% in the placebo group, with the most frequently
reported being asthma worsening/exacerbation (3% versus
6%).
Dr.
Peter A. Merkel, Chief, Division of Rheumatology at Perelman School
of Medicine, University of Pennsylvania & MIRRA study site
investigator said: "Patients suffering from EGPA too often face a
frustrating journey from a delay in receiving a proper diagnosis to
having few effective treatment options with an acceptable safety
profile. Rheumatologists, immunologists, and pulmonologists have an
important role in properly diagnosing and treating patients with
EGPA. Today's approval of mepolizumab provides specialists with the
ability to offer a targeted treatment to appropriate patients with
this complex disease."
Dr.
Michael E. Wechsler, Professor of Medicine at National Jewish
Health in Denver, Colorado, US & Principal Investigator of the
MIRRA study, said: "Patients with EGPA often suffer from recurrent
relapses that place them at greater risk of permanent tissue and
organ damage. Clinical data demonstrated that mepolizumab increased
accrued time in remission, reduced the frequency of relapse and
flares, and enabled patients to have their dose of corticosteroid
reduced compared to placebo in patients already receiving standard
of care. These are key treatment goals and this approval is an
important milestone both for treating physicians and for
patients."
Nucala
for treatment of EGPA in the US is available now. In recognition of
the fact that US consumers are increasingly being asked by their
insurers to take on more cost sharing, making affordability a
concern for some patients, GSK has various patient assistance
programmes available for those who qualify.
About EGPA
Eosinophilic
granulomatosis with polyangiitis is a chronic rare disease that is
caused by inflammation in the walls of small-to-medium sized blood
vessels (vasculitis). The global incidence is generally reported to
be in the range of 1-4 per million, with an estimated prevalence of
approximately 14-45 per million. This translates to approximately
5000 patients with EGPA in the U.S. The mean age of diagnosis is 48
years, and the disease can be life-threatening for some
patients.
In
EGPA, patients typically develop adult-onset asthma, and often
allergic rhinitis and sinusitis. EGPA can result in damage to
lungs, sinuses, skin, heart, gastrointestinal tract, nerves and
other organs. The most common symptoms include extreme fatigue,
muscle and joint pain, weight loss, sinonasal symptoms, and
breathlessness.
The
current approach to disease management is primarily based on
reduction of active inflammation and suppression of the immune
response through the use of corticosteroids 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
and to the risk of relapse, particularly if the dose of
corticosteroid is reduced.
About Nucala (mepolizumab)
First
approved in 2015 for severe eosinophilic asthma, mepolizumab is a
targeted biologic therapy developed to treat diseases which are
driven by inflammation linked to higher-than-normal eosinophils (a
type of white blood cell), being present in the blood. When present
in the body in normal levels, eosinophils can play a role in
protecting the body against infection but over-production can cause
inflammation in vital organs and tissues, sometimes permanently
damaging them.
Mepolizumab
100mg is approved for the treatment of patients with severe
eosinophilic asthma in over 40 countries including the EU, US, and
Japan and has been prescribed to over 18,000 patients in the US.
Mepolizumab 300mg is now approved in the US for the treatment of
adult patients with a rare disease called eosinophilic
granulomatosis with polyangiitis (EGPA). An sBLA has also been
filed for the treatment in patients with chronic obstructive
pulmonary disease (COPD).
Mepolizumab
has been studied in over 3,000 patients in 16 clinical trials
across a number of eosinophilic conditions, and is currently being
investigated for severe hypereosinophilic syndrome and nasal
polyposis.
Trademarks
are owned by or licensed to the GSK group of
companies.
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
four 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.
We
remain at the cutting-edge of scientific research into respiratory
medicine, working in collaboration with patients and the scientific
community to offer innovative medicines aimed at helping to treat
patients' symptoms and reduce the risk of their disease worsening.
While respiratory diseases are clinically distinct, there are
important pathophysiological features that span them, and our
ambition is to have the most comprehensive portfolio of medicines
to address a diverse range of respiratory diseases. To achieve
this, we are focusing on targeting the underlying disease-driving
biological processes to develop medicines with applicability across
multiple respiratory diseases. This approach requires extensive
bioinformatics, data analytic capabilities, careful patient
selection and stratification by phenotype in our clinical
trials.
Important Safety Information (ISI) for Nucala
(mepolizumab)
This
following ISI is based on the Highlights section of the US
Prescribing Information for Nucala. Please consult the full
Prescribing Information for all the labeled safety information for
Nucala.
Nucala
should not be administered to patients with a history of
hypersensitivity to mepolizumab or excipients in the
formulation.
Hypersensitivity
reactions (e.g. anaphylaxis, angioedema, bronchospasms,
hypotension, urticaria, rash) have occurred after administration of
Nucala. Discontinue Nucala in the event of a hypersensitivity
reaction.
Do not
use Nucala to treat acute bronchospasms or status
asthmaticus.
Herpes
zoster has occurred in subjects receiving Nucala in controlled
clinical trials. Consider vaccination if medically
appropriate.
Do not
discontinue systemic or inhaled corticosteroids abruptly upon
initiation of therapy with Nucala. Reductions in corticosteroids
dose, if appropriate, should be gradual and performed under the
direct supervision of a physician.
Treat
patients with pre-existing helminth infections before therapy with
Nucala. If patients become infected while receiving treatment with
Nucala and do not respond to anti-helminth treatment, discontinue
Nucala until parasitic infection resolves.
The
most common adverse reactions reported for Nucala (incidence
≥5%) include headache, injection site reaction, back pain and
fatigue.
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.
Reference
1.
Wechsler M et al. Mepolizumab or Placebo for Eosinophilic
Granulomatosis with Polyangiitis. NEJM;2017:376
Notes to Editors:
Dr.
Peter Merkel and Dr. Mike Wechsler have been contracted by GSK as
consultants.
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GSK
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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David
Daley
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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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Sarah
Spencer
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+1 215
751 3335
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(Philadelphia)
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Mary
Anne Rhyne
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+1 919
483 0492
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(North
Carolina)
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Jenni
Ligday
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+1 202
715 1049
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(Washington,
DC)
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Karen
Hagens
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+1 919
483 2863
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(North
Carolina)
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Gwynne
Oosterbaan
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+1 215
751 7468
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(Philadelphia)
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Anna
Padula
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+1 215
751 4271
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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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Tom
Curry
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+ 1 215
751 5419
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(Philadelphia)
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Gary
Davies
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+44 (0)
20 8047 5503
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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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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
2016.
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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: December
12, 2017
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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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