- Third US indication for Nucala demonstrates GSK’s commitment to
finding new ways to help patients with eosinophil-driven
diseases
GlaxoSmithKline plc (GSK) (LSE/NYSE: GSK) today announced the US
Food and Drug Administration (FDA) has approved Nucala
(mepolizumab) for the treatment of adult and pediatric patients
aged 12 years and older with Hypereosinophilic Syndrome (HES) for ≥
six months without an identifiable non-hematologic secondary cause.
The approval makes Nucala the first and only targeted biologic
treatment to be approved for patients with this eosinophil-driven
disease in the US.
Dr Hal Barron, Chief Scientific Officer and President R&D,
GSK, said: “HES is a complex, life-threatening condition that
impacts nearly 5,000 patients in the US. Today’s approval gives
these patients access to a biologic treatment for the first time
and demonstrates our commitment to maximising Nucala’s impact on
eosinophil-driven diseases.”
The FDA approval follows a priority review of data from a
clinical development programme that included positive results from
a pivotal phase 3 study, recently published in the Journal of
Allergy and Clinical Immunology. The study showed 50 percent fewer
patients experienced a HES flare (worsening of symptoms or
eosinophil threshold requiring an escalation in therapy) when
treated with Nucala, compared to placebo, when added to standard of
care treatment over the 32-week study period (28% vs 56%;
p=0.002).
According to Dr. Gerald Gleich, MD, allergist, immunologist and
a HES expert: “Patients with HES often suffer from debilitating
flares of their disease. Reducing them is an important treatment
goal. For the first time, we now have a biologic treatment option
to offer appropriate patients with this complex disease.”
Patients with HES have a persistent and marked overproduction of
eosinophils, a type of white blood cell. Reducing the
overproduction of eosinophils to normal levels can help people with
eosinophil-driven diseases such as HES.
Mary Jo Strobel, Executive Director, American Partnership for
Eosinophilic Disorders (APFED) added: “HES can take many years to
diagnose and most patients go through a long and frustrating
journey that continues even after the diagnosis is confirmed as
treatment roadmaps are often unclear and limited. APFED welcomes
this approval of Nucala for HES as it gives our community
hope.”
Nucala is currently used as an add-on maintenance therapy for
severe eosinophilic asthma and for the treatment of eosinophilic
granulomatosis with polyangiitis (EGPA), and is being investigated
in several other eosinophil-driven diseases.
Making our products affordable and accessible
GSK is actively involved in creating solutions that allow
patients to have access to new scientific breakthroughs. We remain
committed to helping patients access GSK medications and have a
long history of providing patient assistance programs. Patients and
healthcare professionals who need help with prescription coverage
should visit www.NUCALA.com or call 1-844-4-NUCALA for eligibility
information.
About Hypereosinophilic Syndrome (HES)
HES is a rare and under-diagnosed disorder, making it difficult
to estimate its overall prevalence. Patients with HES have a
persistent and marked overproduction of eosinophils, a type of
white blood cell. People with HES may have eosinophil levels three
times greater than normal. When eosinophils infiltrate certain
tissues, they can cause inflammation and organ damage which, over
time, can impact patients’ day-to-day ability to function.
Complications can range from fever and malaise to respiratory and
cardiac problems. If left untreated, the symptoms of HES become
progressively worse and the disease can be life-threatening.
About the phase 3 study
The pivotal phase 3 study, which enrolled 108 patients, was a
32-week, randomised, double-blind, placebo-controlled study to
investigate the efficacy and safety of subcutaneous mepolizumab
300mg (3x100) every four weeks compared with placebo in patients
aged 12 years and older with uncontrolled HES. Uncontrolled HES was
defined by at least two HES flares (worsening of symptoms or
eosinophil threshold requiring an escalation in therapy) within the
past 12 months and a blood eosinophil count of 1000 cells/µL or
higher at screening.
About Nucala (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
to normal levels. At normal levels eosinophils may play a role in
maintaining health.
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 26 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
and 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 eosinophilic granulomatosis with polyangiitis (EGPA).
Regulatory submissions for chronic rhinosinusitis with nasal polyps
(CRSwNP) are expected to progress in 2020. Mepolizumab is currently
being investigated in COPD. It is not currently approved for use in
CRSwNP or COPD anywhere in the world.
Mepolizumab is not approved for the relief of acute bronchospasm
or status asthmaticus. Full US Prescribing Information is available
at US Prescribing Information Nucala.
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 (eg, 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
(eg, 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.
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 with a special
purpose: to help people do more, feel better, live longer. 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 under Item 3.D
"Risk Factors" in the company's Annual Report on Form 20-F for 2019
and as set out in GSK’s Principal risks and uncertainties” section
of the Q2 Results and any impacts of the COVID-19 pandemic.
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