First and Only Breath-Actuated Aerosol Inhaled Corticosteroid in the United States Designed to Help Eliminate the Need for Hand-Breath Coordination
JERUSALEM — (BUSINESS WIRE) — 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.
QVAR® RediHaler™ product image (Photo: Business Wire)
“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
- Do not use QVAR® RediHaler™ to treat sudden severe symptoms of asthma. Always have a rescue inhaler with you to treat sudden symptoms.
- Do not use QVAR® RediHaler™ if you are allergic to beclomethasone dipropionate or any of the ingredients in QVAR® RediHaler™.
- Do not use QVAR® RediHaler™ more often than prescribed.
- Tell your healthcare provider about all the medicines you take and about all of your health conditions.
- QVAR® RediHaler™ may cause serious side effects, including:
- Fungal infections (thrush) in your mouth and throat. Rinse your mouth with water without swallowing after using QVAR® RediHaler™ to help prevent an infection in your mouth or throat.
- Worsening asthma or sudden asthma attacks. After using your rescue inhaler, contact your healthcare provider right away if you do not get relief from your sudden asthma attacks
- Reduced adrenal function (adrenal insufficiency). This potentially life-threatening condition can happen when you stop taking oral corticosteroid medicines and start using inhaled corticosteroid medicines (such as QVAR® RediHaler™). Tell your healthcare provider right away about any signs and symptoms of adrenal insufficiency such as: feeling tired or exhausted (fatigue); lack of energy; low blood pressure (hypotension); dizziness or feeling faint; nausea and vomiting; or weakness
- Immune system effects and a higher chance for infections. Tell your healthcare provider about any signs or symptoms of infection such as: fever, chills, pain, feeling tired, body aches, nausea, or vomiting
- Increased wheezing (bronchospasm) right after using QVAR® RediHaler™. Always have a rescue inhaler with you to treat sudden wheezing.
- Serious allergic reactions. Stop using QVAR® RediHaler™ and call your healthcare provider or get emergency medical help right away if you get any of the following: hives; swelling of your lips, tongue, or face; rash; or breathing problems
- Slowed growth in children. Children should have their growth checked regularly while using QVAR® RediHaler™.
- Lower bone density. This may be a problem for people who already have a higher chance for low bone density (osteoporosis).
- Eye problems. If you have had glaucoma, cataracts or blurred vision in the past, you should have regular eye exams while using QVAR® RediHaler™.
- Common side effects of QVAR® RediHaler™ include: yeast infection in the mouth (oral candidiasis); cold symptoms (upper respiratory tract infection); pain in the throat (oropharyngeal pain); pain or swelling in your nose and throat (nasopharyngitis); sinus irritation (sinusitis); and hay fever (allergic rhinitis)
- These are not all the possible side effects of QVAR® RediHaler™. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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.
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:
- the potential benefits and uncertainty of commercial success of QVAR® RediHaler™;
- our specialty medicines business, including: competition for our specialty products, especially Copaxone®, our leading medicine, which faces competition from existing and potential additional generic versions and orally-administered alternatives; challenges inherent in product research and development, uncertainty of clinical success and obtaining regulatory approvals as well as our ability to achieve expected results from investments in our product pipeline; competition from companies with greater resources and capabilities; and the effectiveness of our patents and other measures to protect our intellectual property rights;
- our business and operations in general, including: failure to effectively execute the recently announced restructuring plan; uncertainties relating to the potential benefits and success of our new organizational structure and recent senior management changes; our ability to develop and commercialize additional pharmaceutical products; 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 restructuring of our manufacturing network, including potential related labor unrest; the impact of continuing consolidation of our distributors and customers; and variations in patent laws that may adversely affect our ability to manufacture our products;
- 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; potential additional adverse consequences following our resolution with the U.S. government of our FCPA investigation; governmental investigations into sales and marketing practices; potential liability for sales of generic products prior to a final resolution of outstanding patent litigation; 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; and other factors discussed in our Annual Report on Form 20-F for the year ended December 31, 2016 (“Annual Report”), including in the section captioned “Risk Factors,” and in our other filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov and www.tevapharm.com. 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.
References
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.
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