TIDMGSK
RNS Number : 6248E
GlaxoSmithKline PLC
04 November 2015
PRESS
RELEASE
Issued: Wednesday 4 November 2015, London UK - LSE
Announcement
GSK's Nucala(R) (mepolizumab) receives approval from US FDA
- First anti-IL5 treatment for adults and adolescents with
severe asthma with an eosinophilic phenotype
GlaxoSmithKline plc (LSE/NYSE: GSK) today received approval from
the US Food and Drug Administration (FDA) for its Biologics License
Application (BLA) for Nucala(R) (mepolizumab) as an add-on
maintenance treatment of patients with severe asthma aged 12 years
and older, and with an eosinophilic phenotype. Nucala is not
approved for the treatment of other eosinophilic conditions or
relief of acute bronchospasm or status asthmaticus.
Nucala is the first and only approved biologic therapy that
targets interleukin-5 (IL-5), which plays an important role in
regulating the function of eosinophils, an inflammatory cell known
to be important in asthma. It is administered as a 100mg fixed dose
subcutaneous injection every four weeks. Patients will receive
Nucala in addition to their normal medications for severe asthma,
which include high-dose inhaled corticosteroids plus at least one
additional asthma control medicine, and may include oral
corticosteroids.
This is the first marketing authorisation granted for
mepolizumab anywhere in the world.
Eric Dube, Senior Vice President & Head, GSK Global
Respiratory Franchise, said: "Following today's approval, GSK can
now offer, as part of our overall respiratory portfolio, a
first-in-class biologic treatment for severe asthma patients whose
condition is driven by eosinophilic inflammation. Our research has
allowed us to better understand the specific role eosinophils play
in severe asthma. We are proud of our contribution to this emerging
area of science that has led to the approval of the first anti-IL5
treatment. We aim to offer this medicine to patients as soon as
possible."
Patients who were shown to benefit from treatment with
mepolizumab in the Phase III clinical trials were those with blood
eosinophil levels of 150 cells/mcL or greater just prior to
treatment. Further information on eosinophil data is included
within the approved prescribing information.
Professor Ian Pavord, University of Oxford, lead investigator of
the first proof of concept trial for mepolizumab and an
investigator for the Phase III MENSA study said: "Severe asthma is
a debilitating condition in which patients are at high risk of
frequent and serious asthma attacks. Half of all severe asthma
patients have at least one urgent care visit per year. As a
clinician, the prospect of a treatment that can specifically target
the underlying cause of the disease for patients whose condition is
driven by eosinophilic inflammation is exciting."
Full US Prescribing Information is available at US Prescribing
Information Nucala. Prior to the Prescribing Information being
posted online, a copy may be requested from one of the GSK Media or
Investor Relations contacts listed in the "GSK Enquiries" section
at the end of this document.
About asthma
Current estimates indicate that as many as 242 million people
live with asthma worldwide. It is estimated that in the US asthma
affects 25.7 million individuals. For many of these patients,
existing therapies can provide adequate control of their symptoms
if used appropriately. However approximately 5% of patients with
asthma cannot achieve symptom control with existing therapies.
About severe asthma and eosinophilic inflammation
Severe asthma is defined as "asthma which requires treatment
with high dose inhaled corticosteroids (ICS) plus a second
controller (and/or systemic corticosteroids) to prevent it from
becoming 'uncontrolled' or which remains 'uncontrolled' despite
this therapy". Severe asthma patients are also often categorised by
long-term use of oral corticosteroids (OCS). In a sub-set of severe
asthma patients, the over-production of eosinophils (a type of
white blood cell) is known to cause inflammation in the lungs that
can affect the airways, limiting breathing and increasing the
frequency of asthma attacks. 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. Studies suggest that approximately 60% of
patients with severe asthma have eosinophilic airway
inflammation.
For more information on the role of eosinophils in severe asthma
please see GSK's infographic.
About Nucala
Nucala is a monoclonal antibody, which stops IL-5 from binding
to its receptor on the surface of eosinophils. Inhibiting IL-5
binding in this way reduces blood eosinophil levels.
The mepolizumab Phase II/III clinical development programme
involved nine studies and over 1,300 patients. Three key clinical
trials - DREAM (MEA112997), MENSA (MEA115588) and SIRIUS
(MEA115575) - have established the efficacy and safety profile of
Nucala.
The Biologics License Application for Nucala was submitted to
the FDA in November 2014 and was approved on 4 November 2015.
Other mepolizumab regulatory activity
Regulatory applications in a number of other countries,
including the EU and Japan, have been submitted and are under
review. Further submissions are planned during the course of
2016.
Important Safety Information (ISI) for Nucala
The following ISI is based on the Highlights section of the US
Prescribing Information for Nucala.
Please consult the full Prescribing Information for all the
labelled 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., 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.
Do not use Nucala to treat acute bronchospasm or status
asthmaticus. Patients should seek medical advice if their asthma
remains uncontrolled or worsens after initiation of treatment with
Nucala.
In controlled clinical trials, two serious adverse reactions of
herpes zoster occurred in subjects treated with Nucala compared
with none in placebo. Consider varicella vaccination if medically
appropriate prior to starting therapy with Nucala.
Do not discontinue systemic or inhaled corticosteroids abruptly
upon initiation of therapy with Nucala. Reductions in
corticosteroid dose, if appropriate, should be gradual and
performed under the direct supervision of a physician.
Patients with known parasitic infections were excluded from
participation in clinical trials. It is unknown if Nucala will
influence a patient's response against parasitic infections. 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.
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%); upper abdominal pain, 3%
(2%); pruritis, 3% (2%); eczema, 3% (<1%); and muscle spasm, 3%
(<1%).
In three Phase III trials, 10% of subjects in the Nucala group
experienced systemic (allergic and non-allergic) reactions compared
to 7% 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
non-allergic reactions were reported by 2% of subjects in the
Nucala group 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.
Injection site reactions (e.g., pain, erythema, swelling,
itching, and burning sensation) occurred at a rate of 8% in
subjects treated with Nucala compared with 3% in subjects treated
with placebo.
Nucala(R) is a registered trade mark of the GSK group of
companies.
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:
UK Media enquiries: David Mawdsley +44 (0) 20 (London)
8047 5502
Simon Steel +44 (0) 20 (London)
8047 5502
David Daley +44 (0) 20 (London)
8047 5502
Catherine +44 (0) 20 (London)
Hartley 8047 5502
Claire Brough +44 (0) 20 (London)
8047 5502
US Media enquiries: Sarah Alspach +1 202 715 (Washington,
1048 DC)
Sarah Spencer +1 215 751 (Philadelphia)
3335
Mary Anne +1 919 483 (North
Rhyne 0492 Carolina)
Jenni Ligday +1 202 715 (Washington,
1049 DC)
Karen Hagens +1 919 483 (North
2863 Carolina)
Gwynne Oosterbaan +1 215 751 (Philadelphia)
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