- First IL-5 therapy approved as an add-on treatment in the US
for adults with chronic rhinosinusitis with nasal polyps to target
eosinophilic inflammation
- Fourth indication for mepolizumab in the US for
eosinophil-driven diseases
GlaxoSmithKline plc (GSK) today announced that the US Food and
Drug Administration (FDA) has approved Nucala (mepolizumab), a
monoclonal antibody that targets interleukin-5 (IL-5), as a
treatment for patients with chronic rhinosinusitis with nasal
polyps (CRSwNP). This new indication for mepolizumab is for the
add-on maintenance treatment of CRSwNP in adult patients 18 years
of age and older with inadequate response to nasal
corticosteroids.
CRSwNP accounts for 2-4% of the US population, affecting more
than 5 million people. CRSwNP is one of a variety of diseases
arising from inflammation in different tissues associated with
elevated levels of a type of white blood cell called eosinophils.
It is often characterised by raised eosinophil levels, in which
soft tissue growth, known as nasal polyps, develop in the sinuses
and nasal cavity. CRSwNP can cause chronic symptoms such as nasal
obstruction, loss of smell, facial pressure and nasal
discharge.
Mepolizumab is the first anti-IL-5 biologic to be approved for
adult patients with CRSwNP in the US.
Dr. Hal Barron, Chief Scientific Officer and President
R&D, GSK said: “More than 5 million people in the US suffer
with chronic rhinosinusitis with nasal polyps and today’s approval
provides these patients with the first anti-IL-5 treatment option
and an alternative to surgery to help reduce symptoms of this
disease. GSK is committed to exploring the role of IL-5 inhibition
in eosinophil-driven diseases to help address unmet needs of
patients.”
Tonya Winders, CEO & President, Allergy and Asthma
Network (AAN) and President of Global Allergy and Airways Patient
Platform (GAAPP) commented: “Patients with chronic
rhinosinusitis with nasal polyps experience unpleasant symptoms
across a range of severities. As there have been limited treatment
options, particularly for those patients with severe disease, they
may rely on oral steroids and recurrent surgery to manage their
condition. We welcome the news that mepolizumab will now offer
appropriate patients and healthcare providers a novel treatment
option and alternative to surgery.”
The approval of mepolizumab as a treatment for CRSwNP is based
on data from the pivotal SYNAPSE study which explored the effect of
mepolizumab vs. placebo in over 400 patients with CRSwNP.
Mepolizumab achieved significant improvement in reducing the size
of nasal polyps and nasal obstruction. All patients in the study
received standard care, had a history of previous surgery
(approximately one in three had ≥3 surgeries) and were in need of
further surgery due to severe symptoms and increased size of their
polyps. SYNAPSE showed that there was a 57% reduction in the
proportion of patients who had surgery in the group treated with
mepolizumab vs. placebo, HR=0.43 (95% CI 0.25, 0.76). In addition,
the proportion of patients requiring systemic corticosteroid use
during the 52-week treatment period was lower in patients who
received mepolizumab.
Mepolizumab is also approved for use in three other eosinophilic
driven diseases, the first indication being for patients with
severe eosinophilic asthma aged six years and older. Additionally,
mepolizumab was the first biologic therapy indicated for adults
with eosinophilic granulomatosis with polyangiitis (EGPA) and also
the first biologic to be approved for patients aged 12 years and
older with hypereosinophilic syndrome (HES).
With 41 clinical trials, mepolizumab has been studied in over
4,000 patients. GSK is committed to improving the lives of those
living with disease associated with uncontrolled eosinophilic
inflammation, continuously innovating in order to address the unmet
needs in this broad patient group.
Nucala is indicated in the US:
- As an add-on maintenance treatment of adult and pediatric
patients aged 6 years and older with severe asthma and with an
eosinophilic phenotype. Nucala is not indicated for the relief of
acute bronchospasm or status asthmaticus.
- For the treatment of adult patients with EGPA.
- For the treatment of adult and paediatric patients aged 12
years and older with HES for ≥6 months without an identifiable
non-hematologic secondary cause.
- As an add-on maintenance treatment of CRSwNP in adult patients
18 years of age and older with inadequate response to nasal
corticosteroids.
About chronic rhinosinusitis with nasal polyps
(CRSwNP)
CRSwNP is a chronic inflammatory disease of the nasal passage
linings or sinuses which can lead to soft tissue growths known as
nasal polyps and is often characterised by elevated levels of
eosinophils. The resultant swellings can grow in both nostrils
(bilateral) greatly impacting a patient due to various symptoms
including nasal obstruction, loss of smell, facial pressure and
nasal discharge. Surgery may be indicated for severe cases.
However, polyps have a strong tendency to reoccur often leading to
repeat surgery.
About mepolizumab
First approved in 2015 for severe eosinophilic asthma (SEA),
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, reducing blood eosinophils
and maintaining them within normal levels. A normal level of blood
eosinophils being less than 500 eosinophils/microliter. The
mechanism of action for mepolizumab has not been definitively
established.
Mepolizumab has been developed for the treatment of diseases
that are driven by inflammation caused by eosinophils. It has been
studied in over 4,000 patients in 41 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 SEA. It is
approved for paediatric use in SEA from ages six to 17 in Europe,
the US and several other markets. In the US, Japan, Canada and a
number of other markets, it is approved for use in adult patients
with EGPA. Mepolizumab was approved for use in HES in the US in
September 2020, followed by Brazil in February 2021 and Argentina
in May 2021. Mepolizumab is currently being investigated in COPD.
It is not currently approved for use in COPD anywhere in the
world.
Important safety information
The following information is based on the US Prescribing
Information for Nucala in licensed indications only. Please consult
the full Prescribing Information for all the labelled safety
information for Nucala.
CONTRAINDICATIONS
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 after
administration of Nucala. Discontinue Nucala in the event of a
hypersensitivity reaction.
- Do not use to treat acute bronchospasm or status
asthmaticus.
- Herpes zoster infections have occurred in patients receiving
Nucala. Consider vaccination if medically appropriate.
- Do not discontinue systemic or inhaled corticosteroids abruptly
upon initiation of therapy with Nucala. Decrease corticosteroids
gradually, if appropriate.
- 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.
ADVERSE REACTIONS
Most common adverse reactions (incidence ≥5%) in severe asthma
clinical trials included headache, injection site reaction, back
pain, and fatigue. Injection site reactions (e.g. pain, erythema,
swelling, itching, burning sensation) occurred in 8% of subjects
treated with 100 mg of Nucala versus 3% treated with placebo.
In a clinical trial in patients with EGPA receiving 300 mg of
Nucala, no additional adverse reactions were identified to those
reported in severe asthma clinical trials. Injection site reactions
(e.g. pain, erythema, swelling) occurred in 15% of subjects treated
with 300 mg of Nucala versus 13% treated with placebo.
In a clinical trial in patients with hypereosinophilic syndrome,
no additional adverse reactions were identified to those reported
in the severe asthma trials. Injection site reactions (e.g.
burning, itching) occurred in 7% of subjects treated with 300 mg of
Nucala versus 4% treated with placebo.
In a clinical trial with CRSwNP, the most common adverse
reactions (incidence >/= 5%) in patients receiving NUCALA 100 mg
was oropharyngeal pain and arthralgia. Injection site reactions
(e.g., erythema, pruritus) occurred in 2% of patients receiving
Nucala versus <1% treated with placebo.
GSK’s commitment to respiratory disease
For over 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.
About GSK
GSK is a science-led global healthcare company. For further
information please visit www.gsk.com/about-us.
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 in the Company's
Annual Report on Form 20-F for 2020 and any impacts of the COVID-19
pandemic.
Registered in England & Wales: No. 3888792
Registered Office: 980 Great West Road Brentford,
Middlesex TW8 9GS
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210729006206/en/
GSK enquiries: Media enquiries: Tim Foley +44 (0) 20 8047
5502 (London) Kristen Neese +1 804 217 8147 (Philadelphia) Kathleen
Quinn +1 202 603 5003 (Washington DC) Analyst/Investor enquiries:
James Dodwell +44 (0) 20 8047 2406 (London) Sonya Ghobrial +44 (0)
7392 784784 (Consumer) Mick Readey +44 (0) 7990 339653 (London)
Jeff McLaughlin +1 215 751 7002 (Philadelphia) Frannie DeFranco +1
215 751 4855 (Philadelphia)
Gsk (LSE:GSK)
Historical Stock Chart
From Mar 2024 to Apr 2024
Gsk (LSE:GSK)
Historical Stock Chart
From Apr 2023 to Apr 2024