FDA Approves AirDuo Digihaler (fluticasone propionate and salmeterol) Inhalation Powder for Asthma

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has approved AirDuo® Digihaler™ (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, a combination therapy digital inhaler with built-in sensors that connects to a companion mobile application to provide information on inhaler use to people with asthma. AirDuo Digihaler is indicated for the treatment of asthma in patients aged 12 years and older. AirDuo Digihaler is not used to relieve sudden breathing problems and won’t replace a rescue inhaler.

"We are thrilled to be able to expand our Digihaler™ portfolio to now include a maintenance treatment," said Tushar Shah, M.D., Global Head of Specialty Clinical Development at Teva Pharmaceuticals. "With this approval, patients can now track how frequently they are using their inhalers. Granting patients the ability to track their maintenance inhaler use may help inform conversations with their doctors about treatment adherence and proper technique."

Like ProAir® Digihaler™ (albuterol sulfate 117 mcg) inhalation powder, indicated for the treatment or prevention of bronchospasm in patients aged four years and older with reversible obstructive airway disease, and for prevention of exercise-induced bronchospasm (EIB) in patients four years and older, AirDuo® Digihaler™ contains built-in sensors that detect when the inhaler is used and measure inspiratory flow rates. This data is then sent to a companion mobile app using Bluetooth® Wireless Technology so that patients can review their data over time, and if desired, share it with their healthcare providers. Patients can also schedule reminders on their smartphone to take their AirDuo® Digihaler™ as prescribed.

"Even the most diligent asthma patients may not realize they are not following their treatment regimen, despite their best efforts," said Dr. Nabeel Farooqui, MD, FAAAAI, FACAAI, Assistant Professor, Department of Medicine, Indiana University School of Medicine. "The ability to now measure their inspiratory flow rates and track their maintenance medication use, as well as the frequency with which they use their inhaler, may provide important data and insights to help inform treatment discussions with physicians. As a doctor, it’s exciting that my patients are able to share this type of information with me."

The approval of AirDuo Digihaler is based on the review of the supplemental new drug application (sNDA) submitted by Teva to the FDA. AirDuo Digihaler combines a breath-actuated, multi-dose dry powder inhaler with fluticasone propionate, an inhaled corticosteroid (ICS) medicine that may help to decrease inflammation in the lungs, which can lead to breathing problems, and salmeterol, a long acting beta2 adrenergic agonist (LABA), which helps the muscles around the airways in the lungs stay relaxed in order to prevent symptoms. AirDuo Digihaler contains salmeterol. LABA medicines such as salmeterol when used alone increase the risk of hospitalizations and death from asthma problems. AirDuo Digihaler contains an ICS and a LABA. When an ICS and a LABA are used together, there is not a significant increased risk in hospitalizations and death from asthma problems.

AirDuo Digihaler was approved in a low, medium and high dose: 55/14 mcg, 113/14 mcg and 232/14 mcg administered as one inhalation twice daily. As a fixed dose combination asthma therapy containing an ICS and a LABA, AirDuo Digihaler contains the same active ingredients as Advair Diskus, which is also approved in low, medium and high doses: 100/50 mcg, 250/50 mcg and 500/50 mcg.

"For the 25 million Americans living with asthma1, advancements like this one are important and could help patients track their inhaler use and frequency," said Tonya Winders, President & CEO of the Allergy & Asthma Network. "Allowing patients access to both their rescue and maintenance inhaler use information on their smartphones is a promising step towards potentially fostering greater discussions about asthma management."

"The approval of AirDuo Digihaler is an important step for Teva and the respiratory community to create a technology platform for use in asthma management along with the previously-approved ProAir Digihaler," said Sven Dethlefs, Executive Vice President, Global Marketing & Portfolio. "This technology aims at delivering innovations through cloud-based services with the target to provide new insights to guide treatment choices for caregivers to help them improve outcomes for asthma patients."

AirDuo Digihaler is expected to become commercially available to patients by prescription in 2020. For more information, visit www.AirDuoDigihaler.com.

AIRDUO® DIGIHALER™ APPROVED USES

AirDuo Digihaler is a prescription medicine used to control symptoms of asthma and to prevent symptoms such as wheezing in people 12 years of age and older.

AirDuo Digihaler is not used to relieve sudden breathing problems from asthma and won't replace a rescue inhaler.

AirDuo Digihaler contains a built-in electronic module that records and stores information about inhaler events. AirDuo Digihaler may be used with, and transmits information to, a mobile App.

AirDuo Digihaler does not need to be connected to the app in order for you to take your medicine.

AIRDUO® DIGIHALER™ IMPORTANT SAFETY INFORMATION

AirDuo Digihaler contains salmeterol. Long-acting beta2-agonist (LABA) medicines such as salmeterol when used alone increase the risk of hospitalizations and death from asthma problems. AirDuo Digihaler contains an inhaled corticosteroid (ICS) and a LABA. When an ICS and a LABA are used together, there is not a significant increased risk in hospitalizations and death from asthma problems.

Do not use AirDuo Digihaler to treat sudden breathing problems from asthma. Always have a rescue inhaler with you to treat sudden symptoms.

Do not use AirDuo Digihaler if you have a severe allergy to milk proteins or if you are allergic to any of the ingredients in the product. Ask your healthcare provider if you are not sure.

Do not use AirDuo Digihaler more often than prescribed.

Do not take AirDuo Digihaler with other medicines that contain a LABA for any reason.

Tell your healthcare provider about all the medicines you take and about all of your health conditions.

AirDuo Digihaler can cause serious side effects, including:

Fungal infection in your mouth or throat (thrush). Rinse your mouth with water without swallowing after using AirDuo Digihaler to help reduce your chance of getting thrush.

Weakened immune system and increased chance of getting infections (immunosuppression). You should avoid exposure to chickenpox and measles, and, if exposed, tell your healthcare provider right away. Worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infections, or herpes infection of the eye (ocular herpes simplex) may occur.

Reduced adrenal function. This can happen when you stop taking an oral corticosteroid (such as prednisone) and start taking a medicine containing an inhaled corticosteroid (such as AirDuo Digihaler). During this transition period, when your body is under stress such as from fever, trauma (such as a car accident), infection, or surgery, adrenal insufficiency can get worse and may cause death. Symptoms of adrenal insufficiency include:

feeling tired

lack of energy

weakness

nausea and vomiting

low blood pressure

Sudden breathing problems immediately after inhaling your medicine. If you have sudden breathing problems immediately after inhaling your medicine, stop using AirDuo Digihaler and call your healthcare provider right away.

Serious allergic reactions. Stop using AirDuo Digihaler and call your healthcare provider or get emergency medical care if you get any of the following symptoms of a serious allergic reaction:

rash

hives

swelling of your face, mouth, and tongue

breathing problems

Effects on heart

increased blood pressure

a fast or irregular heartbeat

chest pain

Effects on nervous system

tremor

nervousness

Bone thinning or weakness (osteoporosis)

Slowed growth in children. A child's growth should be checked often.

Eye problems including glaucoma and cataracts. You should have regular eye exams while using AirDuo Digihaler.
Changes in laboratory blood values (sugar, potassium, certain types of white blood cells)

Common side effects of AirDuo Digihaler include:

Infection of nose and throat (nasopharyngitis)

thrush in your mouth or throat. Rinse your mouth with water without swallowing after use to help prevent this.

back pain

headache

cough

These are not all the possible side effects of AirDuo Digihaler. Call your healthcare provider for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. 

PROAIR® DIGIHALER™ APPROVED USES

ProAir® Digihaler™ (albuterol sulfate) Inhalation Powder is a prescription medicine used in people 4 years of age and older to:

treat or prevent bronchospasm in people who have reversible obstructive airway disease

prevent exercise-induced bronchospasm

ProAir Digihaler contains a built-in electronic module that detects, records and stores inhaler event information. ProAir Digihaler may be used with, and transmits information to, a mobile app. ProAir Digihaler does not need to be connected to the mobile app in order for you to take your medicine.

IMPORTANT SAFETY INFORMATION

Do not use ProAir Digihaler (albuterol sulfate) Inhalation Powder if you are allergic to albuterol sulfate, lactose, milk proteins, or any of the ingredients in ProAir Digihaler. Ask your healthcare provider if you have any questions or are not sure

Before using ProAir Digihaler, tell your healthcare provider about all of your medical conditions, including if you:

have heart problems

have high blood pressure (hypertension)

have convulsions (seizures)

have thyroid problems

have diabetes

have low potassium levels in your blood

are pregnant or planning to become pregnant

are breastfeeding or planning to breastfeed

Tell your healthcare provider about all the medicines you take, especially:

other inhaled medicines or asthma medicines

beta blocker medicines

diuretics

digoxin

monoamine oxidase inhibitors

tricyclic antidepressants

Do not increase your dose or take extra doses of ProAir Digihaler without first talking to your healthcare provider

Get medical help right away if ProAir Digihaler no longer helps your symptoms, your symptoms get worse or you need to use your inhaler more often

While you are using ProAir Digihaler, do not use other inhaled rescue medicines and asthma medicines unless your healthcare provider tells you to do so

ProAir Digihaler may cause serious side effects, including:

worsening trouble breathing, coughing and wheezing (paradoxical bronchospasm). If this happens, stop using ProAir Digihaler and call your healthcare provider or get emergency help right away. This is more likely to happen with your first use of a new asthma inhalation medicine

heart problems, including faster heart rate and higher blood pressure

possible death in people with asthma who use too much ProAir Digihaler

allergic reactions. Call your healthcare provider right away if you have the following symptoms of an allergic reaction:

itchy skin

swelling beneath your skin or in your throat

rash

worsening trouble breathing

changes in laboratory blood values (sugar, potassium)

The most common side effects of ProAir Digihaler include:

back pain

body aches and pain

upset stomach

sinus headache

urinary tract infection

your heart feels like it is pounding or racing (palpitations)

chest pain

fast heart rate

shakiness

nervousness

headache

dizziness

sore throat

runny nose

These are not all of the possible side effects of ProAir Digihaler. For more information, ask your healthcare provider or pharmacist

You are encouraged to report negative side effects of prescription drugs to the FDA.

About Teva 

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing and producing medicines to improve people’s lives for more than a century. We are a global leader in generic and specialty medicines with a portfolio consisting of over 3,500 different products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of specialty and biopharmaceutical products. 

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