Adults living with asthma now have an
approved rescue treatment designed to treat both symptoms and
inflammation to help prevent asthma attacks
AstraZeneca announces AIRSUPRA® (albuterol/budesonide),
is now commercially available in the US by prescription. AIRSUPRA
received FDA approval in January 2023 for the as-needed treatment
or prevention of symptoms of asthma and to help prevent sudden
severe breathing problems (asthma attacks) in people aged 18 years
and older.1
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AIRSUPRA contains a short-acting beta2-agonist (SABA), to help
relax the smooth muscles of the airways, and an inhaled
corticosteroid (ICS), to help decrease inflammation in the lungs.2
AIRSUPRA was approved based on the results from two Phase III
trials, MANDALA and DENALI. In MANDALA, AIRSUPRA was superior to
albuterol in reducing the risk of severe asthma exacerbations in
patients with moderate to severe asthma. In DENALI, AIRSUPRA had a
similar onset of bronchodilation compared to albuterol in patients
with mild to moderate asthma.2
The approach to treating asthma symptoms with rescue has
changed. The 2023 Global Initiative for Asthma (GINA) report
supports a rescue approach that treats both symptoms and
inflammation together. Combination SABA/ICS is now recommended as a
rescue option for adults with asthma regardless of ICS maintenance
medication.3 According to GINA, recommendations for a change in
rescue approach were largely based on the risk associated with
SABA-only treatment of asthma.3 AIRSUPRA is the only FDA-approved,
as-needed SABA/ICS asthma rescue now available in the US and is
designed to treat both symptoms and inflammation.2,4
Priya Bansal MD, Physician and CEO, Asthma and Allergy Wellness
Center said: “For over five decades, the medical community has used
SABA-only rescue which does not address the inflammatory component
of asthma. Now, with AIRSUPRA available we can provide patients,
especially those on maintenance therapy, another rescue option for
managing their breakthrough symptoms. The MANDALA study has
demonstrated how these patients can benefit from an as-needed
anti-inflammatory rescue to treat their symptoms while helping to
prevent an attack even if they are on ICS-containing maintenance
therapy.”
Liz Bodin, Vice President, US Respiratory & Immunology,
AstraZeneca said: “With AIRSUPRA now available in the US, we are
taking an important step in our mission to revolutionize asthma for
millions of people living with the disease. We are hopeful our
innovative asthma rescue medicine can help alleviate the burden by
addressing both symptoms and underlying inflammation simultaneously
at the right time to reduce the risk of having a severe asthma
attack.”
Those interested in receiving AIRSUPRA are encouraged to speak
with a healthcare provider to determine if AIRSUPRA is an
appropriate treatment option. AstraZeneca is offering a copay
assistance program where eligible patients may pay as little as $0
for AIRSUPRA. To learn more, visit airsupra.com.
IMPORTANT SAFETY INFORMATION
- Do not use AIRSUPRA if you are allergic to albuterol,
budesonide, or any of the ingredients in AIRSUPRA
- Before using AIRSUPRA, tell your healthcare provider
about all your medical conditions and about all the medicines you
take
- A dose of AIRSUPRA is 2 inhalations (puffs) as needed. Use
AIRSUPRA exactly as your healthcare provider tells you to use it.
Do not use AIRSUPRA more than 12 puffs (which equals 6
doses) within a 24-hour period
- AIRSUPRA is not to be used as a maintenance treatment for
asthma. If you are currently taking medicine long-term to
maintain control of asthma symptoms, you should continue to take
that medicine as directed by your healthcare provider
- Do not change or stop other inhaled medicines or asthma
medicines (oral or inhaled) without first talking to your
healthcare provider
- Call your healthcare provider or get emergency medical care
right away if your breathing problems get worse, you need to
use AIRSUPRA more often than usual, or AIRSUPRA does not work as
well to relieve your asthma
- AIRSUPRA can cause serious side effects, including:
- worsening trouble breathing, coughing, and wheezing
(paradoxical bronchospasm). If this happens, stop using
AIRSUPRA and call your healthcare provider or get emergency medical
care right away. This is more likely to happen with your first use
of a new canister of medicine
- heart problems, including faster heart rate and higher blood
pressure
- possible death in people who use too much AIRSUPRA
- serious allergic reactions. Tell your healthcare
provider or get emergency medical care right away if you have a
skin rash, redness, or swelling; severe itching; swelling of the
face, mouth, or tongue; trouble breathing or swallowing; or chest
pain
- changes in laboratory blood levels. Low levels of
potassium (hypokalemia) may cause abnormal heart rhythms
- weakened immune system and increased chance of getting
infections
- fungal infection in your mouth and throat (thrush). This
is a common side effect. Rinse your mouth with water, if available,
without swallowing after using AIRSUPRA to help reduce your chance
of getting thrush
- reduced adrenal function (adrenal insufficiency). This
can happen when you start taking a medicine containing an inhaled
corticosteroid (such as AIRSUPRA)
- bone thinning or weakness (osteoporosis)
- eye problems, including glaucoma and cataracts. Your
healthcare provider may suggest having regular eye exams while
using AIRSUPRA. Discuss any eye problems with your healthcare
provider
- Common side effects include headache, cough, and
hoarseness. These are not all the side effects of AIRSUPRA. For
more information, ask your healthcare provider or pharmacist
APPROVED USE
AIRSUPRA combines 2 medicines to be used as needed as a rescue
inhaler in people 18 years of age and older to:
- treat or prevent symptoms of asthma
- help prevent sudden severe breathing problems (asthma attacks
or exacerbations)
Please see full Prescribing Information and
Patient Information and discuss with your doctor.
You may report side effects related to AstraZeneca products.
Notes
Asthma
Asthma is a chronic, inflammatory respiratory disease with
variable symptoms that affects as many as 262 million people
worldwide,5 including approximately 25 million in the US.6
Patients with asthma experience recurrent breathlessness and
wheezing, which varies over time, and in severity and frequency.3
These patients are at risk of severe exacerbations regardless of
their disease severity, adherence to treatment or level of
control.7,8
There are an estimated 136 million asthma exacerbations globally
per year,9 including approximately 10 million in the US6; these are
physically threatening and emotionally significant for many
patients11 and can be fatal.3,10
Inflammation is central to both asthma symptoms7 and
exacerbations.12 Many patients experiencing asthma symptoms use a
SABA (eg, albuterol) as a rescue medicine13-15; however, taking a
SABA alone does not address inflammation, leaving patients at risk
of severe exacerbations,16 which can result in impaired quality of
life,17 hospitalization18 and frequent oral corticosteroid (OCS)
use.18 Treatment of exacerbations with as few as 1-3 short courses
of OCS are associated with an increased risk of adverse health
conditions including type 2 diabetes, depression/anxiety, renal
impairment, cataracts, cardiovascular disease, pneumonia and
fracture.19 International recommendations from the GINA no longer
recommend SABA alone as the preferred rescue therapy.3
AIRSUPRA
AIRSUPRA® (albuterol/budesonide), formerly known as PT027, is a
first-in-class SABA/ICS rescue treatment for asthma in the US, to
be taken as needed. It is an inhaled, fixed-dose combination rescue
medication containing albuterol (also known as salbutamol), a SABA,
and budesonide, a corticosteroid, and has been developed in a pMDI
using AstraZeneca’s Aerosphere delivery technology.
The FDA approval of AIRSUPRA was based on MANDALA and DENALI
Phase III trials (Approval press release). In MANDALA, AIRSUPRA
significantly reduced the risk of severe exacerbations compared to
albuterol in patients with moderate-to-severe asthma when used as
an as-needed rescue medication in response to symptoms. For
patients treated with AIRSUPRA 180 mcg/160 mcg the annualized total
systemic corticosteroids dose when compared with albuterol 180 mcg
was statistically significantly different, with a reduction in mean
annualized dose of 40 mg per patient. In DENALI, AIRSUPRA
significantly improved lung function compared to the individual
components albuterol and budesonide in patients with mild to
moderate asthma.
About AstraZeneca in Respiratory & Immunology
Respiratory & Immunology, part of BioPharmaceuticals, is one
of AstraZeneca’s main disease areas and is a key growth driver for
the Company.
AstraZeneca is an established leader in respiratory care with a
50-year heritage. The Company aims to transform the treatment of
asthma and COPD by focusing on earlier biology-led treatment,
eliminating preventable asthma attacks, and removing COPD as a
top-three leading cause of death. The Company’s early respiratory
research is focused on emerging science involving immune
mechanisms, lung damage and abnormal cell-repair processes in
disease and neuronal dysfunction.
With common pathways and underlying disease drivers across
respiratory and immunology, AstraZeneca is following the science
from chronic lung diseases to immunology-driven disease areas. The
Company’s growing presence in immunology is focused on five mid- to
late-stage franchises with multi-disease potential, in areas
including rheumatology (including systemic lupus erythematosus),
dermatology, gastroenterology, and systemic eosinophilic-driven
diseases. AstraZeneca’s ambition in Respiratory & Immunology is
to achieve disease modification and durable remission for millions
of patients worldwide.
About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company
that focuses on the discovery, development and commercialization of
prescription medicines in Oncology, Rare Diseases and
BioPharmaceuticals, including Cardiovascular, Renal &
Metabolism, and Respiratory & Immunology. Based in Cambridge,
UK, AstraZeneca operates in over 100 countries, and its innovative
medicines are used by millions of patients worldwide. For more
information, please visit www.astrazeneca-us.com and follow us on
social media @AstraZeneca.
References
- AstraZeneca. AIRSUPRA® (PT027) approved in the US for
asthma. [Press release]. Accessed: January 2024.
https://www.astrazeneca-us.com/media/press-releases/2023/airsupra-pt027-approved-in-the-us-for-asthma.html
- AIRSUPRA® (albuterol/budesonide) [prescribing
information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP;
2023.
- Global Initiative for Asthma. Updated May 2023. Accessed:
January 2024. www.ginasthma.org
- US FDA. FDA approves drug combination treatment for adults with
asthma. Accessed: January 2024.
https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-drug-combination-treatment-adults-asthma
- The Global Asthma Report 2022. Accessed: January 2024.
http://globalasthmareport.org/index.html
- Centers for Disease Control and Prevention (CDC). Most Recent
National Asthma Data. Accessed: January 2024.
https://www.cdc.gov/asthma/most_recent_national_asthma_data.htm
- Price D, et al. Asthma control and management in 8,000 European
patients: the REcognise Asthma and LInk to Symptoms and Experience
(REALISE) survey. NPJ Prim Care Respir Med. 2014;24:14009.
- Papi A, et al. Relationship of inhaled corticosteroid adherence
to asthma exacerbations in patients with moderate-to-severe asthma.
J Allergy Clin Immunol Pract. 2018;6(6): 1989-1998.e3.
- Data on File. REF-173201. AstraZeneca Pharmaceuticals LP.
- Fernandes AG, et al. Risk factors for death in patients with
severe asthma. J Bras Pneumol. 2014;40(4):364-372.
- Sastre J, et al. Insights, attitudes, and perceptions about
asthma and its treatment: a multinational survey of patients from
Europe and Canada. World Allergy Organ J. 2016;9:13.
- Wark PA, et al. Asthma exacerbations . 3: Pathogenesis. Thorax.
2006;61(10):909-915.
- Johnson DB, et al. Albuterol. In: StatPearls. Treasure Island
(FL): StatPearls Publishing; November 17, 2023.
- Montemayor T, et al. Albuterol: Often Used and Heavily Abused.
Respiratory Care. November 2021, 66 (Suppl 10) 3603775.
- ClinCalc.com. Albuterol Drug Usage Statistics, United States,
2013-2020. Accessed: January 2024.
https://clincalc.com/DrugStats/Drugs/Albuterol
- Nwaru BI, et al. Overuse of short-acting β2-agonists in asthma
is associated with increased risk of exacerbation and mortality: a
nationwide cohort study of the global SABINA programme. Eur Respir
J. 2020;55(4):1901872.
- Lloyd A, et al. The impact of asthma exacerbations on
health-related quality of life in moderate to severe asthma
patients in the UK. Prim Care Respir J. 2007;16(1):22-27.
- Bourdin A, et al. ERS/EAACI statement on severe exacerbations
in asthma in adults: facts, priorities and key research questions.
Eur Respir J. 2019;54(3):1900900.
- Price DB, et al. Adverse outcomes from initiation of systemic
corticosteroids for asthma: long-term observational study. J Asthma
Allergy. 2018;11:193-204.
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