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First anti-IL5 biologic to give healthcare professionals choice of
how and where their patients receive treatment
GlaxoSmithKline (LSE/NYSE: GSK) today announced that the US Food and
Drug Administration (FDA) has approved two new methods for administering
Nucala (mepolizumab), an autoinjector and a pre-filled safety syringe,
for patients or caregivers to administer once every four weeks, after a
healthcare professional decides it is appropriate. This is the first
anti-IL5 biologic to be licensed in the US for at-home administration,
and the first respiratory biologic to be approved for administration via
This press release features multimedia. View the full release here:
Nucala (mepolizumab) Autoinjector (Photo: Business Wire)
This approval will give healthcare professionals and people living with
severe eosinophilic asthma (SEA) or the rare disease eosinophilic
granulomatosis with polyangiitis (EGPA) the option for Nucala to be
administered outside of a clinical setting by a patient or caregiver
after their healthcare professional agrees this approach is appropriate.
The original lyophilised powder version remains available for
administration by a healthcare professional.
Dr. Hal Barron, Chief Scientific Officer and President, R&D, GSK, said:
“Nucala’s efficacy is well-established and this approval means that, for
the first time, we are able to provide patients living with these
debilitating conditions the option of receiving this important medicine
in their own home.”
Tonya Winders, President, Global Allergy and Asthma Patient Platform
(GAAPP), added: “People living with conditions like severe asthma often
struggle to control their day-to-day symptoms, making routine activities
like attending healthcare appointments a challenge. Empowering patients
to take their medicines at home is an approach that has been successful
in other chronic diseases such as diabetes and rheumatoid arthritis.
GAAPP welcomes this approval for Nucala so it can be administered in a
doctor’s office or in the convenience of a patient’s home.”
The approval is supported by positive patient 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 SEA, or by their caregivers. Both
studies showed patients were able to successfully self-administer
treatment with both the autoinjector and pre-filled syringe after
appropriate training (89-95% and 100% respectively). In addition, the
majority of patients preferred at home self-administration options
compared to in-clinic administration.
A further open-label, parallel-group, single-dose study (NCT03014674)
confirmed that the pharmacokinetic and pharmacodynamic profile of Nucala
administered via pre-filled syringe or autoinjector was comparable to
the originally approved lyophilised formulation.
Following this approval, it is expected that the new administration
options for Nucala will be available in the US shortly.
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.
About eosinophilic granulomatosis with polyangiitis (EGPA)
Eosinophilic granulomatosis with polyangiitis, formerly known as
Churg-Strauss Syndrome, is a chronic rare disease that is caused by
inflammation in the walls of small-to-medium sized blood vessels
(vasculitis). Approximately five people out of every one million will be
diagnosed with EGPA each year worldwide, 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.
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
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 21 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-IL5 biologic therapy approved for paediatric use
from aged six to 17 in Europe in severe eosinophilic asthma. In the US,
Japan and Canada and a number of other markets, it is approved as add-on
maintenance treatment for patients with EGPA. Mepolizumab is currently
being investigated for severe hypereosinophilic syndrome, nasal
polyposis and COPD.
In the US, Nucala (100mg fixed dose subcutaneous injection of
mepolizumab) is licensed as an add-on maintenance treatment for patients
with severe asthma aged 12 years and older, and with an eosinophilic
phenotype. Nucala (3x 100mg subcutaneous injection of mepolizumab) is
licensed for the treatment of adult patients with eosinophilic
granulomatosis with polyangiitis (EGPA). Nucala is not approved for the
relief of acute bronchospasm or status asthmaticus. Full US Prescribing
Information is available at US
Prescribing Information Nucala.
Nucala injection is intended for use under the guidance of a healthcare
provider. A patient may self-inject or the patient caregiver may
administer Nucala injection subcutaneously after the healthcare provider
determines it is appropriate. The healthcare provider should provide
proper training in subcutaneous injection technique and on the
preparation and administration of Nucala injection prior to use
according to the “Instructions for Use.”
Important safety information for Nucala (mepolizumab)
The following information is based on 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.
WARNINGS AND PRECAUTIONS
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.
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’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.
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.
Cautionary statement regarding forward-looking statementsGSK
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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