Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today announced that the U.S. Food and Drug Administration (FDA) has approved AirDuo RespiClick (fluticasone propionate and salmeterol inhalation powder) for adolescent and adult patients with asthma. The medication is delivered via Teva’s RespiClick® breath-activated, multi-dose dry powder inhaler (MDPI) which is used with other approved medicines in Teva’s respiratory product portfolio.
AirDuo 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.
AirDuo RespiClick is expected to become available to patients in the U.S., by prescription, later this year. The product has 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 FDA’s approval of AirDuo RespiClick is supported by data from Teva’s clinical development program, including three Phase III trials which evaluated the efficacy and safety of the treatment in adolescent and adult patients with asthma. In the two double-blind studies, the therapy 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.
About AirDuo 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
- Long-acting beta2-adrenergic agonists (LABA), such as salmeterol, one of the active ingredients in AirDuo RespiClick, increase the risk of asthma-related death. Data from a large placebo-controlled US trial that compared the safety of salmeterol with placebo added to usual asthma therapy showed an increase in asthma-related deaths in subjects receiving salmeterol (13 deaths out of 13,176 subjects treated for 28 weeks on salmeterol versus 3 deaths out of 13,179 subjects on placebo). Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids or other long-term asthma control drugs mitigates the increased risk of asthma-related death from LABA. Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients
- Therefore, when treating patients with asthma, physicians should only prescribe AirDuo RespiClick for patients not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid, or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and a LABA. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g., discontinue AirDuo RespiClick) if possible without loss of asthma control and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid. Do not use AirDuo RespiClick for patients whose asthma is adequately controlled on low- or medium-dose inhaled corticosteroids
- Contraindications: AirDuo RespiClick is contraindicated in
- Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required
- Patients with known severe hypersensitivity to milk proteins or known hypersensitivity to fluticasone propionate or any of the excipients
- Deterioration of Disease and Acute Episodes: Serious acute respiratory events, including fatalities, have been reported when salmeterol, a component of AirDuo RespiClick, has been initiated in patients with significantly wo...
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