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|September 06, 2017 8:00 a.m.|
|Teva To Present New Asthma and COPD Data at the 2017 European Respiratory Society (ERS) International Congress|
New Analyses To Be Presented for Two Respiratory Therapies - CINQAERO®▼ (reslizumab) and DuoResp Spiromax® (budesonide/formoterol fumarate dihydrate)
“Teva is honored to be a part of this esteemed international meeting as
we present compelling data on two important respiratory therapies that
we believe help to address the current needs of patients throughout the
world living with asthma and COPD,” said Alexandra Kropotova, MD, Vice
President, Clinical Development, Respiratory at
Showcasing A Targeted Biologic
Among the accepted abstracts, eight presentations focus on CINQAERO® (reslizumab), a humanized interleukin-5 antagonist monoclonal antibody for the treatment of severe eosinophilic asthma.
An abstract from Teva’s
Two additional abstracts of note will be presented via poster and include post-hoc pooled analyses from two 52-week trials evaluating the effect of reslizumab on reducing clinical asthma exacerbations (CAEs) as well as improving lung function, asthma control and quality of life.
Highlighting Inhaler Technology
Teva will present HEOR data from its breath-actuated inhaler portfolio, evaluating change in exacerbations, oral corticosteroid or antibiotic use and respiratory related hospitalization or emergency department visits after patients switched from Symbicort Turbuhaler® (budesonide/formoterol fumarate dihydrate) to DuoResp Spiromax® (budesonide/formoterol fumarate dihydrate).
Teva-sponsored data to be presented at the 2017
All abstracts are available on the ERS website, and can be accessed here.
Symbicort Turbuhaler® is a registered
trademark of the
About CINQAERO® (reslizumab)
IL-5 and prevents it from binding to the IL-5 receptor, thereby reducing eosinophilic inflammation.
CINQAERO® Important Safety Information
CINQAERO®▼ (reslizumab) 10mg/ml concentrate for solution for infusion Abbreviated Prescribing Information. Presentation: Vial containing either 25mg of reslizumab in 2.5ml or 100mg of reslizumab in 10ml (10 mg/ml). Indications: Add-on therapy in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus another medicinal product for maintenance treatment. Dosage and administration: CINQAERO should be prescribed by physicians experienced in the diagnosis and treatment of severe eosinophilic asthma. Intravenous infusion only. Should be administered as a 20–50 minute intravenous infusion through a sterile, non-pyrogenic infusion, single-use, low protein binding filter (0.2 μm). Must not be administered as a bolus injection or as undiluted concentrate. CINQAERO is intended for long-term treatment. Review treatment at least annually based on disease severity and exacerbation control. See SmPC for dilution instructions and administration. Adults and Elderly: Based on body weight below 35kg or above 199kg; dose is 3mg/kg given once every four weeks. For patients body weight between 35kg and 199kg; refer to dosing in table 1 of SmPC. Children: Not recommended in children and adolescents up to 17 years old. Renal and Hepatic Impairment: No dose adjustment required. Contraindications: Hypersensitivity to active substance or any excipients. Precautions and warnings: Not to be used to treat acute asthma exacerbations. Asthma-related symptoms or exacerbations may occur. Acute systemic reactions, including anaphylactic reactions were observed during or within 20 minutes after infusion. Patients should be monitored during and for an appropriate time following administration. If an anaphylactic reaction occurs, discontinue treatment immediately and permanently. Patients with pre-existing helminth infections should be treated before commencing CINQAERO therapy. If infection occurs during treatment, temporary discontinuation of treatment should be considered. Interactions: No formal drug interaction studies have been performed. Pregnancy: Not recommended. Lactation: Antibodies may be transferred to the newborns through milk. Not recommended during the first few days after birth. See SmPC for further information. Effects on ability to drive and use machines: Negligible influence on the ability to drive and use machines. Adverse reactions: Anaphylactic reaction, malignancies. Common: Blood creatine phosphokinase increased. Consult the Summary of Product Characteristics in relation to other side effects. Overdose: Monitor for signs and symptoms of adverse effects and initiate symptomatic treatment.
Please refer to the Summary of Product Characteristics (SmPC) for full details of Prescribing Information.
About DuoResp Spiromax® (budesonide/formoterol
About Teva Respiratory
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 potential benefits of CINQAERO® and DuoResp Spiromax®, 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:
Teva Pharmaceutical Industries Ltd.