TIDMGSK
RNS Number : 1354Z
GlaxoSmithKline PLC
12 December 2017
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 MIRRA(1) 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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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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END
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