PARMA, ITALY–(Marketwired – June 07, 2016) –
“As regards to the regulatory schedule, we are on track with the plan that foresees the filing [in the EU] by IV quarter of the current year.”
COPD is a respiratory disease characterized by a persistent bronchial obstruction, associated with an increased chronic inflammatory response of the airways to noxious particles or gas. The classic symptoms associated with COPD are dyspnea, chronic coughing and chronic productive sputum. In some cases, an acute worsening of the abovementioned symptoms may occur, triggering COPD exacerbation. A double mechanism is at work in the bronchial obstruction in COPD patients: on one hand, an inflammation of the small airways together with the thickening of the airways walls and increased airflow resistance may occur. On the other, a progressive destruction of lung parenchyma (emphysema) associated with the loss of elastic retraction of the lung may take place. It is important to underline that both mechanisms may coexist, leading to a global airflow reduction throughout the lungs.
CHF 5993 is an investigational fixed triple combination that contains three active ingredients. CHF 5993 is seeking regulatory approval in the European Union and is not currently approved. The safety and efficacy profile have not been fully established or reviewed by the European Medicines Agency or the US Food and Drug Administration.