The US Food and Drug Administration (FDA) recently accepted review of the supplemental New Drug Application (sNDA) filed by Teva Pharmaceuticals‘ novel drug formulation Pro Air RespiClick. The therapy is an albuterol sulphate-based inhalation powder aimed at treatment or prevention of bronchospasm in children aged between 4 to 11 years with reversible obstructive pulmonary disease, and for the prevention of exercise induced bronchospasm (EIB). The sNDA filed by Teva included data from a pediatric clinical trial program conducted earlier that evaluated the safety and efficacy of the treatment in children 4 – 11 years of age. The acceptance of the sNDA for ProAir RespiClick means that after review, an FDA Regulatory Action can be expected by April 2016, which would accelerate the commercialization and marketing of the drug.
ProAir RespiClick was approved earlier by the FDA in March 2015 for the treatment or prevention of bronchospasm in patients aged 12 years and older with reversible obstructive airway disease and for the prevention of EIB. ProAir RespiClick is the only multi-dose, breath-activated, short-acting beta-agonist (SABA) inhaler available to patients in the US. It is unique in its mechanism of action in comparison to currently available counterparts in the market because it utilizes breath-activated technology that enables patients to breathe in to receive a measured dose of the medicine, completely negating the need for hand-breath coordination during inhalation. The most severe side-effects reported as a result of ProAir RespiClick use in patients have all been heart-related, such as an increase in pulse, blood pressure and/or related symptoms.
Commenting on this milestone, Dr. Tushar Shah, MD, senior VP, Teva Global Respiratory Research and Development, said, “The acceptance of the paediatric filing for ProAir RespiClick by the FDA represents an important step forward for Teva in our mission to better serve patients living with respiratory conditions, such as asthma and EIB. With millions of children living with asthma in the United States, it is important to provide this age group with a new option in rescue inhalers that does not require hand-breath coordination during inhalation.”