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|January 30, 2017 8:00 a.m.|
|Teva Announces FDA Approval of Two New RespiClick® Maintenance Inhalers for the Treatment of Asthma|
Approvals Expand Portfolio of Respiratory Medicines Delivered in RespiClick® Inhaler Designed to Eliminate the Need for Hand-Breath Coordination During Inhalation
AirDuoTM RespiClick® is a fixed dose combination product containing the same active ingredients as Advair®. AirDuo™ RespiClick® is a corticosteroid and a long-acting beta2-adrenergic agonist (LABA) indicated for the treatment of asthma in patients aged 12 years and older. ArmonAirTM RespiClick® is an inhaled corticosteroid (ICS) containing the same active ingredient as Flovent®, and is indicated for the maintenance treatment of asthma as prophylactic therapy in patients 12 years and older.
“As a company on the forefront of developing inhaler technologies for
people living with asthma, we are very pleased to now have two
additional RespiClick®-delivered medicines approved for
adolescent and adult patients in the U.S.,” said
Rob Koremans, M.D., President and CEO of Global Specialty Medicines at Teva said, “With these approvals, we now integrate both fixed dose combination and monotherapy into our core, breath-activated RespiClick® device. By expanding our RespiClick portfolio of breath-activated inhalers, we will provide physicians and their patients with additional treatment options in an inhaler device that does not require hand-breath coordination during inhalation.”
AirDuo™ RespiClick® and ArmonAir™ RespiClick® are expected to become available to patients in the U.S., by prescription, later this year. Both products have been approved in three strengths. The approved strengths of AirDuo™ RespiClick® are: 55/14 mcg, 113/14 mcg and 232/14 mcg administered as one inhalation twice daily. The approved strengths of ArmonAir™ RespiClick® are: 55 mcg, 113 mcg, and 232 mcg administered as one inhalation twice daily.
“Prescribing the lowest effective dose of a medication is a key clinical
objective in the treatment of asthma. It’s equally important that
patients use their asthma inhalers correctly to ensure medicine is
reaching the lungs,” said Dr.
The FDA’s approval of AirDuo™ RespiClick® and ArmonAir™ RespiClick® is supported by data from Teva’s clinical development program, including three Phase III trials which evaluated the efficacy and safety of the treatments in adolescent and adult patients with asthma. In the two double-blind studies, both therapies showed clinically relevant and greater benefit compared with placebo in the improvement of lung function after 12 weeks of treatment as measured by Forced Expiratory Volume in one second (FEV1). In clinical trials for AirDuo™ RespiClick®, the most common adverse reactions (incidence ≥3%) were nasopharyngitis, headache, cough, oral candidiasis and back pain. In ArmonAir™ RespiClick® clinical trials, the most common adverse reactions (incidence ≥3%) were nasopharyngitis, headache, cough, oral candidiasis and upper respiratory tract infection.
About AirDuoTM RespiClick® (Fluticasone Propionate and Salmeterol) Inhalation Powder
AirDuo™ RespiClick® is indicated for the treatment of asthma in patients aged 12 years and older. AirDuo RespiClick is only for patients uncontrolled on an ICS or whose disease severity clearly warrants an ICS/LABA.
Important Limitation of Use: AirDuo RespiClick is NOT indicated for the relief of acute bronchospasm.
IMPORTANT SAFETY INFORMATION
WARNING: ASTHMA-RELATED DEATH
Please click here for full Prescribing Information, including Boxed
About ArmonAirTM RespiClick® (Fluticasone Propionate) Inhalation Powder
ArmonAir™ RespiClick® is indicated for the maintenance treatment of asthma as prophylactic therapy in patients 12 years of age and older.
Important Limitation of Use: ArmonAir RespiClick is NOT indicated for the relief of acute bronchospasm.
IMPORTANT SAFETY INFORMATION
Please click here for full Prescribing Information: http://armonairrespiclick.com/assets/pdf/PI.pdf. Prior to the availability of full Prescribing Information online, 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.
Asthma is a chronic (long term) disease usually characterized by airway inflammation and narrowing of the airways, which can vary over time. Asthma may cause recurring periods of wheezing (a whistling sound when you breathe), chest tightness, shortness of breath and coughing that often occurs at night or early in the morning. Without appropriate treatment, asthma symptoms may become more severe and result in an asthma attack, which can lead to hospitalization and even death.
About Teva Respiratory
Teva Respiratory develops and delivers high-quality treatment options for respiratory conditions, including asthma, COPD and allergic rhinitis. The Teva Respiratory portfolio is centered on optimizing respiratory treatment for patients and healthcare providers through the development of novel delivery systems and therapies that help address unmet needs. The company’s respiratory pipeline and clinical trial program are based on drug molecules delivered in proprietary dry powder formulations and breath-activated device technologies, as well as a targeted biologic treatment for severe asthma. Through research and clinical development, Teva Respiratory continually works to expand, strengthen and build upon its treatment portfolio to positively impact the lives of the millions of patients living with respiratory disease.
Teva's Safe Harbor Statement under the
This release contains forward-looking statements, which are based on management’s current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause our future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: our ability to develop and commercialize additional pharmaceutical products; competition for our specialty products, especially Copaxone® (which faces competition from orally-administered alternatives and a generic version); our ability to realize the anticipated benefits of the acquisition of Allergan plc’s worldwide generic pharmaceuticals business (“Actavis Generics”), and the timing of realizing such benefits; our ability to fully and efficiently integrate Actavis Generics and to achieve the anticipated cost savings, synergies, business opportunities and growth prospects from the combination; the fact that we are now dependent to a much larger extent than previously on our generic pharmaceutical business; our ability to develop and launch new generic products from the Actavis Generics pipeline on the anticipated timelines; potential restrictions on our ability to engage in additional transactions or incur additional indebtedness as a result of the substantial amount of debt we have incurred to finance the Actavis Generics acquisition; the fact that we will have significantly less cash on hand than prior to the consummation of the Actavis Generics acquisition, which could adversely affect our ability to grow; our ability to achieve expected results from investments in our pipeline of specialty and other products; our ability to identify and successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions; the extent to which any manufacturing or quality control problems damage our reputation for quality production and require costly remediation; increased government scrutiny in both the U.S. and Europe of our patent settlement agreements; our exposure to currency fluctuations and restrictions as well as credit risks; the effectiveness of our patents, confidentiality agreements and other measures to protect the intellectual property rights of our specialty medicines; the effects of reforms in healthcare regulation and pharmaceutical pricing, reimbursement and coverage; competition for our generic products, both from other pharmaceutical companies and as a result of increased governmental pricing pressures; governmental investigations into sales and marketing practices, particularly for our specialty pharmaceutical products; adverse effects of political or economic instability, major hostilities or acts of terrorism on our significant worldwide operations; interruptions in our supply chain or problems with internal or third-party information technology systems that adversely affect our complex manufacturing processes; significant disruptions of our information technology systems or breaches of our data security; competition for our specialty pharmaceutical businesses from companies with greater resources and capabilities; the impact of continuing consolidation of our distributors and customers; decreased opportunities to obtain U.S. market exclusivity for significant new generic products; potential liability in the U.S., Europe and other markets for sales of generic products prior to a final resolution of outstanding patent litigation; our potential exposure to product liability claims that are not covered by insurance; any failure to recruit or retain key personnel, including, in particular, former Actavis Generics personnel who have transitioned to Teva or to attract additional executive and managerial talent; any failures to comply with complex Medicare and Medicaid reporting and payment obligations; significant impairment charges relating to intangible assets, goodwill and property, plant and equipment; the effects of increased leverage and our resulting reliance on access to the capital markets; potentially significant increases in tax liabilities; 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; variations in patent laws that may adversely affect our ability to manufacture our products in the most efficient manner; environmental risks; the possibility of additional adverse consequences arising from our recent FCPA-related settlement with the U.S. government, including limitations on our conduct of business in various countries, adverse judgments in shareholder lawsuits and fines, penalties or other sanctions imposed by government authorities in other countries; and other factors that are discussed in our Annual Report on Form 20-F for the year ended December 31, 2015 and in our other filings with the U.S. Securities and Exchange Commission (the SEC). 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, whether as a result of new information, future events or otherwise.
Teva Pharmaceutical Industries Ltd.