TIDMGSK
RNS Number : 0487B
GlaxoSmithKline PLC
04 June 2019
Issued: Tuesday 4 June 2019, London UK - LSE announcement
Nucala (mepolizumab) receives positive CHMP opinion for new
self-administration options
GlaxoSmithKline (LSE/NYSE: GSK) today announced that the
European Medicines Agency's (EMA) Committee for Medicinal Products
for Human Use (CHMP) has issued a positive opinion recommending two
new methods for administering Nucala (mepolizumab) to patients with
severe eosinophilic asthma: a pre-filled pen and a pre-filled
safety syringe, to be taken once every four weeks.
If approved, the two new Nucala options will offer healthcare
professionals the choice of prescribing at-home administration for
appropriate patients. The original lyophilised powder version
remains available for administration in clinic by a healthcare
professional.
A CHMP positive opinion is one of the final steps before
marketing authorisation is granted by the European Commission.
Data supporting the recommendation
The CHMP opinion is supported by positive experience data from
two open-label, single-arm, phase IIIa studies (NCT03099096 &
NCT03021304) evaluating the real-world use of Nucala administered
via the new options in clinic and at home by patients with severe
eosinophilic asthma, or their caregivers. Both studies showed
patients were able to successfully self-administer treatment with
both the pre-filled pen and pre-filled safety syringe after
appropriate training (89-95% and 100% respectively). In addition,
the majority of patients preferred at-home administration options
compared to in-clinic administration.
A further open-label, parallel-group, single-dose
pharmacokinetic and pharmacodynamic study (NCT03014674), confirmed
that the profile of Nucala administered via the pre-filled safety
syringe or pre-filled pen was comparable to the originally approved
lyophilised formulation.
About Nucala (mepolizumab)
First approved in 2015 for severe eosinophilic asthma,
mepolizumab is the first-in-class monoclonal antibody that targets
IL-5. It is believed to work by preventing IL-5 from binding to its
receptor on the surface of eosinophils. Inhibiting IL-5 binding in
this way reduces blood eosinophils.
Mepolizumab has been developed for the treatment of diseases
that are driven by inflammation caused by eosinophils. It has been
studied in over 3,000 patients in 16 clinical trials across a
number of eosinophilic indications and has been approved (under the
brand name Nucala) in the US, Europe and in over 20 other markets,
as an add-on maintenance treatment for patients with severe
eosinophilic asthma. It is also the only anti IL-5 biologic therapy
approved for paediatric use from ages six to 17 in Europe in severe
eosinophilic asthma. In the US, Japan, Canada and a number of other
markets, it is also approved as add-on maintenance treatment for
patients with eosinophilic granulomatosis with polyangiitis (EGPA).
Mepolizumab is currently being investigated for severe
hypereosinophilic syndrome, nasal polyposis and COPD.
In Europe, Nucala is indicated as an add-on treatment for severe
refractory eosinophilic asthma in adults, adolescents and children
aged 6 years and older.
Nucala 100mg solution for injection in pre-filled pen and
pre-filled syringe are only appropriate for use by adults and
adolescents aged 12 years and over and are not indicated for
administration to children aged 6 to 11 years old. This population
should be treated with the lyophilised powder for solution for
injection.
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.
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.
GSK's commitment to respiratory disease
For 50 years, GSK has led the way in developing medicines that
advance the management of asthma and COPD. From introducing the
world's first selective short-acting beta agonist in 1969, to
launching six treatments in five years to create today's
industry-leading respiratory portfolio, we continue to innovate so
we can reach the right patients, with the right treatment. Working
together with the healthcare community, we apply world-class
science to discover and understand the molecules that become the
medicines of tomorrow. We won't stand still until the simple act of
breathing is made easier for everyone.
Important safety information for Nucala (mepolizumab)
The following Important Safety Information is based on a summary
of the European Summary of Product Characteristics and Prescribing
Information for Nucala. Please consult the full Summary of Product
Characteristics and Prescribing Information for all the safety
information for Nucala.
Nucala is contraindicated in patients with hypersensitivity to
mepolizumab or to any of the excipients.
Nucala should not be used to treat acute asthma
exacerbations.
Asthma-related adverse symptoms or exacerbations may occur
during treatment. Patients should be instructed to seek medical
advice if their asthma remains uncontrolled or worsens after
initiation of treatment.
Abrupt discontinuation of corticosteroids after initiation of
Nucala therapy is not recommended. Reduction in corticosteroid
doses, if required, should be gradual and performed under the
supervision of a physician.
Acute and delayed systemic reactions, including hypersensitivity
reactions (e.g. anaphylaxis, urticaria, angioedema, rash,
bronchospasm, hypotension), have occurred following administration
of Nucala. These reactions generally occur within hours of
administration, but in some instances have a delayed onset (i.e.,
typically within several days). These reactions may occur for the
first time after a long duration of treatment.
Eosinophils may be involved in the immunological response to
some helminth infections. Patients with pre-existing helminth
infections should be treated for the helminth infection before
starting therapy with Nucala. If patients become infected whilst
receiving treatment with Nucala and do not respond to anti-helminth
treatment, temporary discontinuation of therapy should be
considered.
In clinical studies in subjects with severe refractory
eosinophilic asthma, the most commonly reported adverse reactions
during treatment were headache, injection site reactions and back
pain. Headache was considered very common, occurring with a
frequency of >=1/10. Common adverse drug reactions (>=1/100
to <1/10) included: lower respiratory tract infection, urinary
tract infection, pharyngitis, hypersensitivity reactions (systemic,
allergic), nasal congestion, upper abdominal pain, eczema, back
pain, administration-related reaction (systemic, non-allergic),
local injection site reactions, and pyrexia. Severe allergic
reactions (anaphylaxis) is a rare side effect (may affect up to 1
in 1,000 people).
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.
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
Trademarks are owned by or licensed to the GSK group of
companies.
GSK enquiries:
UK Media enquiries: Simon Steel +44 (0) 20 8047 (London)
5502
Tim Foley +44 (0) 20 8047 (London)
5502
US Media enquiries: Evan Berland +1 215 751 5497 (Philadelphia)
Analyst/Investor Sarah Elton-Farr +44 (0) 20 8047 (London)
enquiries: 5194
James Dodwell +44 (0) 20 8047 (London)
2406
Danielle Smith +44 (0) 20 8047 (London)
7562
Jeff McLaughlin +1 215 751 7002 (Philadelphia)
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 2018.
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END
MSCUGUUWQUPBUQC
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