First and Only Breath-Actuated Aerosol Inhaled Corticosteroid in the United States Designed to Help Eliminate the Need for Hand-Breath Coordination
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced today that QVAR® RediHaler™ (beclomethasone dipropionate HFA) Inhalation Aerosol is now commercially available to patients in both 40 mcg and 80 mcg strengths by prescription in the U.S. QVAR® RediHaler™ is the first and only breath-actuated aerosol inhaled corticosteroid for the maintenance treatment of asthma as a prophylactic therapy in patients 4 years of age and older. It is not indicated for the relief of acute bronchospasm.
“When it comes to the treatment of asthma, proper inhaler technique remains a critical issue for patients. In fact, nearly 68 percent of patients do not use their metered dose inhalers (MDIs) well enough to benefit from the prescribed medication1, leading to potentially uncontrolled asthma symptoms2,” said Dr. Warner W. Carr, MD, Associate Medical Director of Southern California Research at Allergy and Asthma Associates of Southern California Medical Group. “As a physician, it’s often a challenge to know if my patients are using their inhalers correctly once they leave the office. It’s reassuring to see new device technologies come to market, such as the QVAR® RediHaler™ device, which is designed specifically to eliminate the need for hand-breath coordination.”
QVAR® RediHaler™ differs from conventional metered-dose inhalers (MDIs) as it delivers medication via a breath-actuated inhaler, eliminating the need for hand-breath coordination during inhalation. QVAR® RediHaler™ administers the same active ingredient found in the previously available QVAR® (beclomethasone dipropionate HFA) Inhalation Aerosol, but utilizes innovative breath-actuated inhaler technology. QVAR® RediHaler™ was also designed to be ready for use, with no shaking or priming needed. Because the medication delivery is breath actuated, it should not be used with a spacer or volume holding chamber.
“QVAR® has been an available asthma treatment option for well over a decade, so we are excited by the new technology of QVAR® RediHaler™ that directly addresses an unmet need in the field of asthma management,” said Brendan O’Grady, Executive Vice President, North America Commercial at Teva. “By merging our breath-actuated inhaler technology with asthma medication, we hope to better serve the needs of the respiratory community and look forward to seeing the adoption of QVAR® RediHaler™ in the coming months.”
With the launch of QVAR® RediHaler™, Teva is discontinuing sales of the previously available QVAR®. Patients currently prescribed QVAR® and/or their caregivers are encouraged to speak with a healthcare professional about how this new treatment option may impact their treatment plan and how to obtain and use QVAR® RediHaler™, if desired. QVAR® RediHaler™ will be priced at parity to QVAR®.
Approved Use
QVAR® RediHaler™ (beclomethasone dipropionate HFA) Inhalation Aerosol is a breath-actuated inhaled prescription medicine used as a maintenance treatment for the prevention and control of asthma in people 4 years of age and older.
QVAR® RediHaler™ Inhalation Aerosol is not used to relieve sudden breathing problems and won’t replace a rescue inhaler.
Important Safety Information
Please see full Prescribing Information at http://www.qvarredihaler.com/Pdf/PI.pdf
A copy may be requested from the US Medical Information Contact Center for Teva Specialty Medicines at 888-4-TEVA-RX (888-483-8279) and USMedInfo@tevapharm.com or Teva’s Public Relations or Investor Relations contacts.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading global pharmaceutical company that delivers high-quality, patient-centric healthcare solutions used by millions of patients every day. Headquartered in Israel, Teva is the world’s largest generic medicines producer, leveraging its portfolio of more than 1,800 molecules to produce a wide range of generic products in nearly every therapeutic area. In specialty medicines, Teva has a world-leading position in innovative treatments for disorders of the central nervous system, including pain, as well as a strong portfolio of respiratory products. Teva integrates its generics and specialty capabilities in its global research and development division to create new ways of addressing unmet patient needs by combining drug development capabilities with devices, services and technologies. Teva's net revenues in 2017 were $22.4 billion. For more information, visit www.tevapharm.com.
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 the U.S. launch of QVAR® RediHaler™, 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:
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1. Fink JB, Rubin BK. Problems with inhaler use: a call for improved
clinician and patient education. Respir Care. 2005;50(10):1360-1374.
2.
D. Price, S. Bosnic-Anticevich, A. Briggs, H. Chrystyn, C. Rand, G.
Scheuch, J. Bousquet. Inhaler competence in asthma:Common errors,
barriers to use and recommended solutions. Respiratory Medicine. 2013;
107:37-46.
Teva Pharmaceutical Industries Ltd.
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