New asthma indication for Trelegy Ellipta introduces an
important option for patients to the current treatment paradigm
GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ:
INVA) announced the US Food and Drug Administration (FDA) has
approved a new indication for Trelegy Ellipta (fluticasone furoate
/ umeclidinium / vilanterol ‘FF/UMEC/VI’) for the treatment of
asthma in patients aged 18 years and older adding to its current
license for use in patients with chronic obstructive pulmonary
disease (COPD). Trelegy Ellipta is not indicated for relief of
The FDA-approved strength for both COPD and asthma is
fluticasone furoate / umeclidinium / vilanterol 100/62.5/25mcg.
There is an additional strength for asthma alone which is
fluticasone furoate / umeclidinium / vilanterol 200/62.5/25mcg.
The approval means Trelegy is the first single inhaler triple
therapy approved for the maintenance treatment of both asthma and
COPD and is the only single inhaler triple therapy available for
patients in a convenient once-daily inhalation in the US. Today’s
announcement marks GSK’s sixth major medicine approval in 2020
across areas of significant unmet medical need including cancer,
HIV, respiratory and chronic kidney disease.
Dr Hal Barron, Chief Scientific Officer and President R&D,
GSK, said: “Millions of asthma patients in the US rely on multiple
inhalers to help control their condition and manage their symptoms.
Today’s approval is an important advance for these patients as it
allows them to benefit from triple therapy by using one inhaler,
Trelegy’s approval for the maintenance treatment of asthma in
patients aged 18 years and older introduces a new paradigm for
managing the approximately 30% of adult asthma patients who still
experience symptoms despite being adherent to inhaled
corticosteroids/long-acting beta agonist (ICS/LABA) combination
Tonya Winders, President, Global Allergy and Airways Patient
Platform (GAAPP) commented: “In the US there are almost 20 million
adultsi living with asthma and we know that many of those continue
to live with and adapt their lives around ongoing symptoms, despite
taking medication as prescribed by their physician. We welcome the
news that for appropriate patients, Trelegy Ellipta will now be
available as a new treatment option.”
Today’s approval was based on a supplemental New Drug
Application which included data from the CAPTAIN study showing that
in patients uncontrolled on ICS/LABA, the additional
bronchodilation provided by Trelegy demonstrated significant
improvements in lung function compared with FF/VI, in a single
daily dose in an easy-to-use inhaler. The results from CAPTAIN were
presented at the European Respiratory Society (ERS) Congress this
week, reinforcing the potential of once-daily single inhaler triple
therapy in asthma management.
Pavel Raifeld, Chief Executive Officer of Innoviva, said: “In
2017, Trelegy Ellipta was approved in the US as the first
once-daily single inhaler triple therapy for the treatment of COPD,
and it remains the market leader with strong continued growth.
Today’s approval in asthma is another successful outcome for our
long-standing partnership with GSK and a testament to our
commitment to make innovative medicines accessible to patients with
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
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.
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 COPD. Trelegy Ellipta was approved in
the US on 9 September 2020 for the maintenance treatment of asthma
in patients aged 18 years and older. Trelegy Ellipta is not
indicated for relief of acute bronchospasm.
US Prescribing Information for Trelegy Ellipta.
Important Safety Information (ISI) for Trelegy
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
Trelegy Ellipta is NOT indicated for the relief of acute
Trelegy Ellipta is contraindicated in primary treatment of
status asthmaticus or acute episodes of asthma requiring intensive
measures and in patients with severe hypersensitivity to milk
proteins or any of the ingredients.
LABA monotherapy increases the risk of serious asthma-related
Trelegy Ellipta should not be initiated in patients experiencing
episodes of acutely deteriorating COPD or asthma. 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
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, discontinue Trelegy Ellipta
If paradoxical bronchospasm occurs, discontinue Trelegy Ellipta
and institute alternative therapy.
Hypersensitivity reactions such as anaphylaxis, angioedema,
rash, and urticaria may occur after administration of TRELEGY.
Discontinue TRELEGY if such reactions occur.
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
Orally inhaled corticosteroids may reduce growth velocity in
children and adolescents. Trelegy Ellipta is not indicated for use
in children and adolescents.
COPD: The most common adverse reactions reported for Trelegy
Ellipta 100/62.5/25 mcg (incidence ≥1%) are upper respiratory tract
infection, pneumonia, bronchitis, oral candidiasis, headache, back
pain, arthralgia, influenza, sinusitis, pharyngitis, rhinitis,
dysgeusia, constipation, urinary tract infection, diarrhoea,
gastroenteritis, oropharyngeal pain, cough, and dysphonia.
Asthma: The most common adverse reactions (incidence ≥2%) are
nasopharyngitis, upper respiratory tract infection, bronchitis,
viral respiratory tract infection, sinusitis, urinary tract
infection, rhinitis, influenza, headache, and back pain.
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 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.
Trade marks are owned by or licensed to the GSK group of
Editor’s Note: In addition to the FDA’s approval of
Trelegy Ellipta in asthma, GSK has received five major medicine
approvals to date in 2020 for CABENUVA (cabotegravir and
rilpivirine) in Canada, DUVROQ (daprodustat) in Japan, and ZEJULA
(niraparib), RUKOBIA (fostemsavir) and BLENREP (belantamab
mafodotin) in the US.
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
Cautionary statement regarding forward-looking
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.
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
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