FDA Approves ProAir Digihaler
JERUSALEM–(BUSINESS WIRE)–Dec 21, 2018–Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has approved ProAir ® Digihaler™ (albuterol sulfate 117 mcg) inhalation powder, the first and only digital inhaler with built-in sensors which connects to a companion mobile application and provides inhaler use information to people with asthma and COPD. ProAir ® Digihaler™ is 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 aged four years and older.
“This approval marks a significant milestone not only for Teva, but for the respiratory community as it allows patients and their caregivers to better understand inhaler usage through digital technology,” said Sven Dethlefs, Executive Vice President, Global Marketing & Portfolio. “Teva recognizes the importance of integrating technology into patient care, and we are very proud to lead the way with the approval of ProAir ® Digihaler™. The digital technology built into ProAir ® Digihaler™ provides patients with data on their inhaler use, which may help them to have a more informed dialogue with their healthcare provider regarding their asthma or COPD management.”
ProAir ® Digihaler™ contains built-in sensors that detect when the inhaler is used and measure inspiratory flow. This inhaler-use data is then sent to the companion mobile app using Bluetooth ® Wireless Technology so patients can review their data over time, and if desired, share it with their healthcare professionals.
“There are 25 million Americans living with asthma1, many of whom use inhalers as part of their treatment regimen. Despite advancements in care over the years, we know that many are using their rescue medications incorrectly2 or too often3,” said Tonya Winders, President & CEO of the Allergy & Asthma Network. “The FDA approval of ProAir ® Digihaler ™ is significant because it may help patients track their inhaler usage and provide data that can be used to work more closely with their HCPs on their asthma management. This approval is a major step forward and is indicative of how medications are evolving through technological innovations.”
The approval of ProAir ® Digihaler™ is based on the review of a supplemental new drug application (sNDA) submitted by Teva to the FDA. ProAir ® Digihaler™ combines a breath-activated, multi-dose dry powder inhaler with albuterol, the most widely used asthma rescue medication, with a built-in electronic module and a companion mobile app.
“One of the challenges physicians are faced with in caring for their asthma and COPD patients is knowing if their patients are using their inhaled medication as they should. That’s what makes a product like this so important to doctor-patient discussions,” said Tushar Shah, M.D., Global Head of Specialty Clinical Development & Medical Affairs at Teva Pharmaceuticals. “Offering a tool that enables doctors to see data on their patients’ inhaler usage will allow them to have more productive conversations about identifying issues and how to manage their illness.”
ProAir ® Digihaler™ will be available in 2019 through a small number of “Early Experience” Programs, which will be conducted in partnership with healthcare systems and in limited geographies, in order to gather real-world experience. A national launch is planned for 2020. For more information, visit www.ProAirDigihaler.com.
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
- other inhaled medicines or asthma medicines
- beta blocker medicines
- monoamine oxidase inhibitors
- tricyclic antidepressants
- 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
- worsening trouble breathing
- 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
- sore throat
- runny nose
Please read the full Prescribing Information.
Teva Pharmaceutical Industries Ltd. is a global leader in generic medicines, with innovative treatments in select areas, including CNS, pain and respiratory. We deliver high-quality generic products and medicines in nearly every therapeutic area to address unmet patient needs. We have an established presence in generics, specialty, OTC and API, building on more than a century-old legacy, with a fully integrated R&D function, strong operational base and global infrastructure and scale. We strive to act in a socially and environmentally responsible way. Headquartered in Israel, with production and research facilities around the globe, we employ 45,000 professionals, committed to improving the lives of millions of patients. Learn more at www.tevapharm.com.
Teva Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding ProAir ® Digihaler™, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to:the uncertainty of commercial success of ProAir ® Digihaler™. our ability to successfully compete in the marketplace, including: that we are substantially dependent on our generic products; competition for our specialty products, especially COPAXONE ® , our leading medicine, which faces competition from existing and potential additional generic versions and orally-administered alternatives; competition from companies with greater resources and capabilities; efforts of pharmaceutical companies to limit the use of generics including through legislation and regulations; consolidation of our customer base and commercial alliances among our customers; the increase in the number of competitors targeting generic opportunities and seeking U.S. market exclusivity for generic versions of significant products; price erosion relating to our products, both from competing products and increased regulation; delays in launches of new products and our ability to achieve expected results from investments in our product pipeline; our ability to take advantage of high-value opportunities; the difficulty and expense of obtaining licenses to proprietary technologies; and the effectiveness of our patents and other measures to protect our intellectual property rights; our substantially increased indebtedness and significantly decreased cash on hand, which may limit our ability to incur additional indebtedness, engage in additional transactions or make new investments, may result in a further downgrade of our credit ratings; and our inability to raise debt or borrow funds in amounts or on terms that are favorable to us; our business and operations in general, including: failure to effectively execute our restructuring plan announced in December 2017; uncertainties related to, and failure to achieve, the potential benefits and success of our new senior management team and organizational structure; harm to our pipeline of future products due to the ongoing review of our R&D programs; our ability to develop and commercialize additional pharmaceutical products; potential additional adverse consequences following our resolution with the U.S. government of our FCPA investigation; compliance with sanctions and other trade control laws; manufacturing or quality control problems, which may damage our reputation for quality production and require costly remediation; interruptions in our supply chain; disruptions of our or third party information technology systems or breaches of our data security; the failure to recruit or retain key personnel; variations in intellectual property laws that may adversely affect our ability to manufacture our products; challenges associated with conducting business globally, including adverse effects of political or economic instability, major hostilities or terrorism; significant sales to a limited number of customers in our U.S. market; our ability to successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions; and our prospects and opportunities for growth if we sell assets; compliance, regulatory and litigation matters, including: costs and delays resulting from the extensive governmental regulation to which we are subject; the effects of reforms in healthcare regulation and reductions in pharmaceutical pricing, reimbursement and coverage; governmental investigations into sales and marketing practices; potential liability for patent infringement; product liability claims; increased government scrutiny of our patent settlement agreements; failure to comply with complex Medicare and Medicaid reporting and payment obligations; and environmental risks; other financial and economic risks, including: our exposure to currency fluctuations and restrictions as well as credit risks; potential impairments of our intangible assets; potential significant increases in tax liabilities; and the effect on our overall effective tax rate of the termination or expiration of governmental programs or tax benefits, or of a change in our business; and other factors discussed in our Annual Report on Form 10-K for the year ended December 31, 2017, including in the section captioned “Risk Factors,” and in our other filings with the U.S. Securities and Exchange Commission, which are available at and . Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.
The Bluetooth ® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Teva Pharmaceutical Industries Ltd. is under license. Other trademarks and trade names are those of their respective owners.
1. National Center for Health Statistics. Centers for Disease Control. Asthma. 2014. http://www.cdc.gov/nchs/fastats/asthma.htm.
2. Fink JB, Rubin BK. Problems with inhaler use: a call for improved clinician and patient education. Respir Care. 2005;50(10):1360-1374.
3. The Journal of Allergy and Clinical Immunology: In Practice. Quantifying beta-agonist utilization: Occasions or puffs?, September 13, 2018. Accessed on October 10, 2018. Available at: https://www.sciencedirect.com/science/article/pii/S2213219818305774?via%3Dihub
SOURCE: Teva Pharmaceutical Industries Ltd.
Posted: December 2018
ProAir Digihaler (albuterol sulfate) FDA Approval History
Source: Read Full Article