MARLBOROUGH, Mass.--(BUSINESS WIRE)--Sunovion
Pharmaceuticals Inc. (Sunovion) today announced that the U.S. Food
and Drug Administration (FDA) approved the New Drug Application (NDA)
for Lonhala™ Magnair™ (glycopyrrolate) Inhalation Solution (25
mcg twice daily), also known as SUN-101/eFlow®, for the
long-term, maintenance treatment of airflow obstruction in people with
chronic obstructive pulmonary disease (COPD), including chronic
bronchitis and/or emphysema. Sunovion expects LONHALA MAGNAIR to be
available in U.S. pharmacies in early 2018.
LONHALA MAGNAIR is the first nebulized long-acting muscarinic antagonist
(LAMA) approved for the treatment of COPD in the U.S. and the first use
of the MAGNAIR, which is based on the closed eFlow®
technology system, developed by PARI Pharma GmbH, to treat COPD. This
technology is a virtually silent, portable, closed system nebulizer that
is designed to deliver the drug in two to three minutes and allows
people to breathe normally while using the device.
“We are proud that the FDA has approved LONHALA MAGNAIR as the first
nebulized, long-acting muscarinic antagonist treatment option for people
in the U.S. living with COPD,” said David Frawley, Executive Vice
President and Chief Commercial Officer at Sunovion. “The approval of
LONHALA MAGNAIR underscores our leadership in nebulization and the value
we place on providing innovative treatment options for people living
with COPD. LONHALA MAGNAIR is an important addition to our portfolio of
approved COPD therapies for people at various stages of COPD, providing
the flexibility to choose handheld or nebulized products based on
individual needs.”
“Despite the availability of several therapies, many people still
struggle to control their COPD – a challenge that may be affected by the
delivery method used to administer a medication,” said Gary Ferguson,
M.D., Pulmonary Research Institute of Southeast Michigan, Farmington
Hills, Michigan. “LONHALA MAGNAIR offers an important new option that
combines the efficacy of a proven medication for COPD with the
attributes of a unique handheld nebulizer that allows a person to
breathe normally while taking their medication.”
Approximately 15.7 million adults in the U.S. report they have been
diagnosed with COPD, a common, preventable and treatable disease that is
characterized by persistent respiratory symptoms and airflow limitation
that is due to airway and/or lung abnormalities usually caused by
significant exposure to toxic particles or gases.1,2 The main
risk factor for COPD is tobacco smoking, but other environmental
exposures may contribute.2 The disease makes it hard for
people to breathe and subsequently may limit their ability to perform
some routine activities, including the proper inhalation of medication.2
This improper medication technique may impact treatment over time and
may also result in an inadequate amount of the drug reaching the lungs,
potentially worsening a person’s COPD.3,4,5 For people with
moderate-to-very-severe COPD, nebulized treatments offer an alternative
to inhalers, allowing a person to breathe normally while taking their
medicine.
The approval is based on data from the clinical trials in the
Glycopyrrolate for Obstructive Lung Disease via Electronic Nebulizer
(GOLDEN) program, which included GOLDEN-3 and GOLDEN-4, two Phase 3,
12-week, randomized, double-blind, placebo-controlled, parallel-group,
multicenter, efficacy and safety trials comparing LONHALA MAGNAIR with
placebo in adults with moderate-to-very-severe COPD. At study endpoints,
individuals treated with LONHALA MAGNAIR demonstrated statistically
significant and clinically important changes from baseline in trough
forced expiratory volume in one second (FEV1) at Week 12
versus placebo. An additional study, GOLDEN-5, was a Phase 3, 48-week,
randomized, open-label, active-controlled, parallel-group, multicenter
safety trial designed to evaluate the long-term safety and tolerability
of LONHALA MAGNAIR in adults with moderate-to-very-severe COPD and
included the active comparator Spiriva® (tiotropium bromide)
delivered by the HandiHaler® device. LONHALA MAGNAIR was
generally well-tolerated in clinical studies, with the most common side
effects being exacerbations and cough. The overall treatment emergent
adverse events (TEAE) incidences were similar for glycopyrrolate and
tiotropium groups over 48 weeks.
Anyone seeking medical information, patient assistance and other
information about LONHALA MAGNAIR can access Sunovion Answers by calling
1-844-276-8262 Monday through Friday from 8:00 a.m. to 8:00 p.m. ET.
About Lonhala™ Magnair™ (glycopyrrolate) Inhalation Solution
LONHALA MAGNAIR (glycopyrrolate) Inhalation Solution, also known as
SUN-101/eFlow®, is the first long-acting muscarinic
antagonist (LAMA) bronchodilator delivered via the MAGNAIR, which is
based on the closed eFlow® technology system, developed by
PARI Pharma GmbH. The MAGNAIR nebulizer is a virtually silent, portable
delivery device that reduces the amount of time required to deliver the
drug to two to three minutes and allows people to breathe normally while
using the device. LONHALA MAGNAIR is approved for the long-term,
maintenance treatment of airflow obstruction in people with chronic
obstructive pulmonary disease (COPD), including chronic bronchitis
and/or emphysema.
Important Safety Information for LONHALA MAGNAIR (glycopyrrolate)
Inhalation Solution
INDICATION
LONHALA™ MAGNAIR™ (glycopyrrolate) is a medicine called an
anticholinergic. LONHALA MAGNAIR is used long term, twice each day
(morning and evening), for maintenance treatment of chronic obstructive
pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
IMPORTANT SAFETY INFORMATION
LONHALA MAGNAIR does not relieve sudden symptoms of COPD and should not
be used more than twice daily. Always have a short-acting beta2-agonist
with you to treat sudden symptoms.
Do not use LONHALA MAGNAIR unless your health care provider has taught
you how to use the device and you understand how to use it correctly.
Use LONHALA MAGNAIR exactly as your health care provider tells you to
use it.
Do not use LONHALA MAGNAIR more often than is prescribed for you. Do not
stop using LONHALA MAGNAIR or other medicines to control or treat your
COPD unless told to do so by your health care provider because your
symptoms might get worse. Your health care provider will change your
medicines as needed.
Get emergency medical care if your breathing problems worsen quickly,
you need to use your rescue medication more often than usual, or your
rescue medication does not work as well to relieve your symptoms.
Do not use LONHALA MAGNAIR if you are allergic to glycopyrrolate or to
any of the ingredients in LONHALA MAGNAIR. Ask your health care provider
if you are not sure.
Tell your health care provider about all of your health conditions,
including if you:
-
have kidney problems
-
have eye problems such as glaucoma
-
have prostate or bladder problems, or problems passing urine
-
have any other medical conditions
-
are pregnant or plan to become pregnant
-
are breastfeeding or plan to breastfeed
-
are allergic to LONHALA MAGNAIR or any of its ingredients, or to any
other medicines or food products
Tell your health care provider about all the medicines you take,
including prescription medicines, over-the-counter medicines, vitamins,
and herbal supplements. LONHALA MAGNAIR and certain other medicines may
interact with each other. This may cause serious side effects.
Especially tell your health care provider if you take anticholinergics
(including umeclidinium, tiotropium, ipratropium, aclidinium,
glycopyrrolate).
LONHALA MAGNAIR can cause serious side effects, including:
-
sudden shortness of breath (that may be life-threatening) immediately
after use of LONHALA MAGNAIR
-
serious allergic reactions, including: rash; hives; swelling of the
tongue, lips, and face; and difficulty breathing or swallowing. Call
your health care provider or get emergency medical care if you get any
symptoms of a serious allergic reaction
-
new or worsened eye problems, including acute narrow-angle glaucoma
(symptoms may include eye pain or discomfort, blurred vision, red
eyes, nausea or vomiting, seeing halos or bright colors around lights)
-
new or worsened urinary retention (symptoms may include difficulty
urinating, urinating frequently, painful urination, urination in a
weak stream or drips)
Common side effects of LONHALA MAGNAIR include shortness of breath and
urinary tract infection.
These are not all of the possible side effects with LONHALA MAGNAIR.
Tell your health care provider about any side effect that bothers you or
that does not go away.
LONHALA solution is for oral inhalation only and should not be injected
or swallowed. LONHALA vials should only be administered with MAGNAIR.
You are encouraged to report side effects of prescription drugs to the
FDA. Visit www.fda.gov/medwatch
or call 1-800-FDA-1088.
This information is not comprehensive.
How to get more information:
-
Talk to your health care provider
-
Visit
www.LonhalaMagnair.com
to obtain the FDA-approved product labeling
-
Call 1-888-394-7377
For additional information, please see full
Prescribing
Information
and Patient Information for LONHALA MAGNAIR at
www.LonhalaMagnair.com
.
About Long-Acting Muscarinic Antagonists (LAMAs)
A long-acting muscarinic antagonist (LAMA) is a type of long-acting
bronchodilator, along with long-acting beta2-agonists
(LABAs). According to the GOLD 2017 report, these are currently the
first-line standard of care maintenance therapy for symptomatic
individuals with COPD, and help the muscles around the airways in lungs
stay relaxed to prevent symptoms such as wheezing, coughing, chest
tightness and shortness of breath.2,6 LAMAs are widely used
and an important therapeutic approach for people with COPD.
About the Phase 3 GOLDEN Clinical Trials
GOLDEN-3 and GOLDEN-4 were pivotal Phase 3, 12-week, randomized,
double-blind, placebo-controlled, parallel-group, multicenter, efficacy
and safety trials comparing LONHALA MAGNAIR with placebo in adults with
moderate-to-very-severe COPD. The GOLDEN-3 trial enrolled 653 people who
were at least 40 years old at 45 sites in the United States. The
GOLDEN-4 trial enrolled 641 people who were at least 40 years old at 49
sites in the United States. LONHALA MAGNAIR 25 mcg, LONHALA MAGNAIR 50
mcg or placebo was administered twice daily in these studies. The
primary endpoint was the change from baseline in trough FEV1
at Week 12. Key secondary endpoints included standardized change from
baseline at Week 12 in FEV1 area under the curve (AUC),
change from baseline in trough forced vital capacity (FVC) at Week 12,
change from baseline in health status measured by St. George’s
Respiratory Questionnaire (SGRQ) and change in rescue medication use.
Safety was assessed by the number of treatment emergent adverse events
(TEAE), serious adverse events (SAE) or major adverse cardiac events
(MACE) and the number and percentage of study participants who
discontinued due to TEAEs. Both GOLDEN-3 and GOLDEN-4 studies included
not only people who were taking effective background long-acting
bronchodilator therapy but also individuals with very severe disease and
co-existing cardiovascular illness. Approximately 10 percent of the
population were elderly (>75 years), 65 percent were classified as being
high-risk cardiovascular individuals and approximately 30 percent were
taking long-acting bronchodilator therapy [NCT02347761 and NCT02347774].
GOLDEN-5 was a Phase 3, 48-week, randomized, open-label,
active-controlled, parallel-group, multicenter safety trial designed to
evaluate the long-term safety and tolerability of LONHALA MAGNAIR in
adults with moderate-to-very-severe COPD. The study enrolled 1,087
individuals at 111 investigational sites in the United States and
Europe. The study evaluated 50 mcg of LONHALA MAGNAIR delivered
twice-daily and active comparator 18 mcg of Spiriva®
(tiotropium bromide) delivered once-daily by the HandiHaler®
device. The primary safety endpoints were: the number and percentage of
study participants with TEAEs, the number and percentage of study
participants with treatment emergent SAEs, the number and percentage of
study participants who discontinued due to TEAEs. Secondary endpoints
included the mean change from baseline over 48 weeks in trough FEV1
for all subjects and the number and incidence of subjects with MACE. The
study included not only people who were taking effective background
long-acting bronchodilator therapy but also individuals with very severe
disease and co-existing significant cardiovascular illness.
Approximately 10 percent of the population were elderly (>75 years), 65
percent were classified as being high-risk cardiovascular individuals
and more than 40 percent were taking long-acting bronchodilator therapy
[NCT02276222].
About COPD
Chronic obstructive pulmonary disease (COPD) is a common, preventable
and treatable disease that is characterized by persistent respiratory
symptoms and airflow limitation that is due to airway and/or lung
abnormalities usually caused by significant exposure to toxic particles
or gases. The main risk factor for COPD is tobacco smoking, but other
environmental exposures may contribute.2 Approximately 15.7
million adults in the U.S. report that they have been diagnosed with
COPD.1 It is estimated that several million more adults have
undiagnosed COPD.7 COPD is responsible for over 120,000
deaths per year, making it the third leading cause of death in the U.S.1
COPD develops slowly and the symptoms often worsen over time,
potentially limiting the ability to perform routine activities.2
Symptoms of COPD include coughing, wheezing, shortness of breath, excess
production of mucus in the lungs, the inability to breathe deeply and
the feeling of being unable to breathe.6 The symptoms of COPD
can be most severe during the night and early morning.8 Morning
symptoms can be associated with limitation of activities during the day,
impaired health status and increased risk of exacerbation.9
Night-time symptoms disturb sleep, reduce sleep quality and, in the long
term, may be associated with development or worsening of cardiovascular
diseases, cognition, depression and increased mortality.10
About Sunovion Pharmaceuticals Inc. (Sunovion)
Sunovion is a global biopharmaceutical company focused on the innovative
application of science and medicine to help people with serious medical
conditions. Sunovion’s vision is to lead the way to a healthier world.
The company’s spirit of innovation is driven by the conviction that
scientific excellence paired with meaningful advocacy and relevant
education can improve lives. With patients at the center of everything
it does, Sunovion has charted new paths to life-transforming treatments
that reflect ongoing investments in research and development and an
unwavering commitment to support people with psychiatric, neurological
and respiratory conditions. Sunovion’s track record of discovery,
development and/or commercialization of important therapies has included
Lonhala™ Magnair™ (glycopyrrolate) Inhalation Solution, Utibron™
Neohaler® (indacaterol/glycopyrrolate) Inhalation Powder,
Seebri™ Neohaler®
(glycopyrrolate)
Inhalation Powder, Arcapta Neohaler (indacaterol) Inhalation Powder,
Brovana® (arformoterol tartrate) Inhalation Solution, Latuda®
(lurasidone HCI) and Aptiom® (eslicarbazepine acetate).
Headquartered in Marlborough, Mass., Sunovion is an indirect,
wholly-owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd. Sunovion
Pharmaceuticals Europe Ltd., based in London, England, and Sunovion
Pharmaceuticals Canada Inc., based in Mississauga, Ontario, are
wholly-owned direct subsidiaries of Sunovion Pharmaceuticals Inc.
Additional information can be found on the company’s websites: www.sunovion.com,
www.sunovion.eu
and www.sunovion.ca.
Connect with Sunovion on Twitter,
LinkedIn,
Facebook
and YouTube.
About Sumitomo Dainippon Pharma Co., Ltd.
Sumitomo Dainippon Pharma is among the top-ten listed pharmaceutical
companies in Japan operating globally in major pharmaceutical markets,
including Japan, the United States, China and the European Union.
Sumitomo Dainippon Pharma aims to create innovative pharmaceutical
products in the Psychiatry & Neurology area and the Oncology area, which
have been designated as the focus therapeutic areas. Sumitomo Dainippon
Pharma is based on the merger in 2005 between Dainippon Pharmaceutical
Co., Ltd., and Sumitomo Pharmaceuticals Co., Ltd. Today, Sumitomo
Dainippon Pharma has about 6,500 employees worldwide. Additional
information about Sumitomo Dainippon Pharma is available through its
corporate website at www.ds-pharma.com.
LATUDA and SUNOVION are registered trademarks of Sumitomo Dainippon
Pharma Co., Ltd.
BROVANA is a registered trademark of Sunovion
Pharmaceuticals Inc.
APTIOM is a registered trademark of BIAL, used
under license.
SEEBRI and UTIBRON are trademarks of Novartis AG,
used under license.
ARCAPTA and NEOHALER are registered trademarks
of Novartis AG, used under license.
LONHALA is a trademark of
Sunovion Pharmaceuticals Inc.
MAGNAIR is a trademark of PARI Pharma
GmbH, used under license.
eFlow and eLete
are
registered trademarks of PARI Pharma GmbH.
Spiriva and Handihaler
are registered trademarks of Boehringer Ingelheim Pharma GMBH & Co KG.
Sunovion Pharmaceuticals Inc. is a U.S. subsidiary of Sumitomo Dainippon
Pharma Co., Ltd.
© 2017 Sunovion Pharmaceuticals Inc.
All rights reserved.
For a copy of this release, visit Sunovion’s web site at www.sunovion.com
References
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2
GOLD Guidelines 2017. http://www.goldcopd.org/guidelines-global-strategy-for-diagnosis-management.html.
Accessed: March 16, 2017.
3 Singh S, Loke YK. An
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Restrepo RD, Alvarez MT, Wittnebel LD, et al. Medication adherence
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Taffet GE, Donohue JF, Altman PR. Considerations for managing chronic
obstructive pulmonary disease in the elderly. Clinical Interventions
in Aging. 2014;9:23-30. doi:10.2147/CIA.S52999.
6
National Heart, Lung and Blood Institute. (2013). “What Are the Signs
and Symptoms of COPD?” Retrieved from https://www.nhlbi.nih.gov/health/health-topics/topics/copd/signs.
7
National Heart, Lung, and Blood Institute. “What is COPD?” Available at: http://www.nhlbi.nih.gov/health/educational/copd/what-is-copd/index.htm.
Accessed: March 2, 2016.
8 Partridge MR, Karlsson N,
Small IR. Patient insight into the impact of chronic obstructive
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Agusti A, Hedner J, Marin JM, Barbé F, Cazzola M, Rennard S. Night-time
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