AirDuo® Digihaler™
Teva Pharmaceutical Industries Ltd. issued the following announcement on July 15.
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 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. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
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™ 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. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088
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. Learn more at www.tevapharm.com
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