GlaxoSmithKline plc (GSK) and Innoviva, Inc. (INVA) today
announced the filing of a supplemental New Drug Application (sNDA)
to the US Food and Drug Administration (FDA) seeking an additional
indication for the use of once-daily, single-inhaler triple
therapy, Trelegy Ellipta (fluticasone
furoate/umeclidinium/vilanterol or FF/UMEC/VI), for the treatment
of asthma in adults. Trelegy Ellipta was approved in the US in
September 2017 for the treatment of patients with Chronic
Obstructive Pulmonary Disease (COPD).
The submission is supported by the pivotal Phase III clinical
study (CAPTAIN), conducted in 2,436 adult patients with
uncontrolled asthma across 15 countries. Positive headline results
were reported in May 2019.
Although asthma is understood to be an inflammatory condition,
additional bronchodilation administered through multiple-inhalers
has been proven to have a beneficial effect on asthma symptoms and
lung function. Single-inhaler triple therapy would introduce a new
treatment paradigm for managing those adult patients who remain
symptomatic on an ICS/LABA combination.
Christopher Corsico, SVP Development, GSK said: “Around 30% of
asthma patients adherent to ICS/LABA combination therapy still
experience symptoms. This filing is an important step towards
giving asthma patients an additional treatment option. If approved,
this filing would make Trelegy Ellipta the first and only single
inhaled triple therapy available for both asthma and COPD in the
US.”
About asthma
Asthma is a chronic lung disease that inflames and narrows the
airways. Asthma affects 358 million people worldwide. Despite
medical advances, more than half of patients continue to experience
poor control and significant symptoms impacting their daily
lives.
The causes of asthma are not completely understood but likely
involve an interaction between a person’s genetic make-up and the
environment. Key risk factors are inhaled substances that provoke
allergic reactions or irritate the airways.
About the CAPTAIN Study
CAPTAIN (Clinical study of
Asthma Patients receiving Triple therapy through A single INhaler) was
a randomised, double-blind, active controlled, six-arm parallel
group, global multicentre study evaluating FF/UMEC/VI (100/62.5/25
mcg, 200/62.5/25 mcg, 100/31.25/25 mcg, and 200/31.25/25 mcg)
versus FF/VI (100/25 mcg and 200/25 mcg) given once-daily to
patients whose asthma was inadequately controlled despite treatment
with ICS/LABA (>250 mcg/day fluticasone propionate, or
equivalent) maintenance asthma medication. In the study 2,436
patients were treated across 15 countries.
About Trelegy Ellipta (FF/UMEC/VI) in the US
FF/UMEC/VI is a combination of three molecules in a single
inhaler that only needs to be taken in a single inhalation, once a
day. It contains fluticasone furoate, an inhaled corticosteroid,
umeclidinium, a long-acting muscarinic antagonist; and vilanterol,
a long-acting beta2-adrenergic agonist, delivered in GSK’s Ellipta
dry powder inhaler.
FF/UMEC/VI was approved in the US under the brand name Trelegy
Ellipta in September 2017 for the long-term, once-daily maintenance
treatment of patients with chronic obstructive pulmonary disease
(COPD). Trelegy Ellipta is not indicated for relief of acute
bronchospasm or for the treatment of asthma.
US Prescribing Information for Trelegy Ellipta.
Important Safety Information (ISI) for Trelegy
Ellipta
The following ISI is based on the Highlights section of the US
Prescribing Information for Trelegy Ellipta. Please consult the
full Prescribing Information for all the labelled safety
information.
Trelegy Ellipta is NOT indicated for the relief of acute
bronchospasm or for the treatment of asthma.
Trelegy Ellipta is contraindicated in patients with severe
hypersensitivity to milk proteins or any of the ingredients.
LABA monotherapy increases the risk of serious asthma-related
events.
Trelegy Ellipta should not be initiated in patients experiencing
episodes of acutely deteriorating COPD. Do not use Trelegy Ellipta
to treat acute symptoms.
Trelegy Ellipta should not be used in combination with other
medicines containing LABA because of risk of overdose.
Candida albicans infection of the mouth and pharynx has occurred
in patients treated with fluticasone furoate, a component of
Trelegy Ellipta. Monitor patients periodically. Advise the patient
to rinse his/her mouth with water without swallowing after
inhalation to help reduce the risk.
There is an increased risk of pneumonia in patients with COPD
taking Trelegy Ellipta. Monitor patients for signs and symptoms of
pneumonia.
Patients who use corticosteroids are at risk for potential
worsening of infections (e.g. existing tuberculosis; fungal,
bacterial, viral, or parasitic infections; or ocular herpes
simplex). Use Trelegy Ellipta with caution in patients with these
infections. More serious or even fatal course of chickenpox or
measles can occur in susceptible patients.
There is a risk of impaired adrenal function when transferring
from systemic corticosteroids. Taper patients slowly from systemic
corticosteroids if transferring to Trelegy Ellipta.
Hypercorticism and adrenal suppression may occur with very high
dosages or at the regular dosage of Trelegy Ellipta in susceptible
individuals. If such changes occur, consider appropriate
therapy.
If paradoxical bronchospasm occurs, discontinue Trelegy Ellipta
and institute alternative therapy.
Use Trelegy Ellipta with caution in patients with cardiovascular
disorders because of beta-adrenergic stimulation.
Assess patients for decrease in bone mineral density initially
and periodically thereafter after prescribing Trelegy Ellipta.
Consider referral to an ophthalmologist in patients who develop
ocular symptoms or use TRELEGY ELLIPTA long term. Worsening of
narrow-angle glaucoma may occur. Use with caution in patients with
narrow-angle glaucoma and instruct patients to contact a healthcare
provider immediately if symptoms occur.
Worsening of urinary retention may occur in patients taking
Trelegy Ellipta. Use with caution in patients with prostatic
hyperplasia or bladder-neck obstruction and instruct patients to
contact a healthcare provider immediately if symptoms occur.
Use Trelegy Ellipta with caution in patients with convulsive
disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis.
Be alert to hypokalemia and hyperglycemia in patients taking
Trelegy Ellipta.
The most common adverse reactions reported for Trelegy Ellipta
(incidence ≥1%) are upper respiratory tract infection, pneumonia,
bronchitis, oral candidiasis, headache, back pain, arthralgia,
influenza, sinusitis, pharyngitis, rhinitis, dysgeusia,
constipation, urinary tract infection, diarrhea, gastroenteritis,
oropharyngeal pain, cough, and dysphonia.
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.
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.
Trade marks are owned by or licensed to the GSK group of
companies.
About Innoviva
Innoviva is focused on royalty management. Innoviva's portfolio
is anchored by the respiratory assets partnered with Glaxo Group
Limited (GSK), including RELVAR®/BREO® ELLIPTA®, ANORO® ELLIPTA®
and TRELEGY® ELLIPTA®, which were jointly developed by Innoviva and
GSK. Under the agreement with GSK, Innoviva is eligible to receive
associated royalty revenues from RELVAR®/BREO® ELLIPTA® and ANORO®
ELLIPTA®. In addition, Innoviva retains a 15 percent economic
interest in future payments made by GSK for TRELEGY® ELLIPTA® and
earlier-stage programs partnered with Theravance Biopharma, Inc.
For more information, please visit Innoviva's website at
www.inva.com.
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.
Innoviva forward-looking statements
This press release contains certain "forward-looking" statements
as that term is defined in the Private Securities Litigation Reform
Act of 1995 regarding, among other things, statements relating to
goals, plans, objectives and future events, including the
development, regulatory and commercial plans for closed triple
combination therapy and the potential benefits and mechanisms of
action of closed triple combination therapy. Innoviva intends such
forward-looking statements to be covered by the safe harbor
provisions for forward-looking statements contained in Section 21E
of the Securities Exchange Act of 1934 and the Private Securities
Litigation Reform Act of 1995. Such forward-looking statements
involve substantial risks, uncertainties and assumptions. These
statements are based on the current estimates and assumptions of
the management of Innoviva as of the date of this press release and
are subject to risks, uncertainties, changes in circumstances,
assumptions and other factors that may cause the actual results of
Innoviva to be materially different from those reflected in the
forward-looking statements. Important factors that could cause
actual results to differ materially from those indicated by such
forward-looking statements are described under the headings "Risk
Factors" and "Management's Discussion and Analysis of Financial
Condition and Results of Operations" contained in Innoviva's Annual
Report on Form 10-K for the year ended December 31, 2018, which is
on file with the Securities and Exchange Commission (SEC) and
available on the SEC's website at www.sec.gov. Additional factors
are described in those sections of Innoviva's Quarterly Report on
Form 10-Q for the quarter ended June 30, 2019. In addition to the
risks described above and in Innoviva's other filings with the SEC,
other unknown or unpredictable factors also could affect Innoviva's
results. No forward-looking statements can be guaranteed and actual
results may differ materially from such statements. Given these
uncertainties, you should not place undue reliance on these
forward-looking statements. The information in this press release
is provided only as of the date hereof, and Innoviva assumes no
obligation to update its forward-looking statements on account of
new information, future events or otherwise, except as required by
law.
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Registered Office: 980 Great West Road Brentford,
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