Novartis has received a positive opinion recommending EU approval of QAB149 for maintenance bronchodilator treatment in adult patients with chronic obstructive pulmonary disease (COPD).
The company said that when approved, QAB149 and its device, concept-1, will be known as Onbrez Breezhaler.
The company said that the positive opinion for two dose strengths of QAB149, 150mcg and 300mcg, has been issued by the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA).
According to the results from pivotal phaseIII trials, presented at the European Respiratory Society (ERS) 2009 Annual Congress in Vienna, showed QAB149 significantly improved lung function and provided clinically relevant improvement in symptoms of breathlessness compared to tiotropium, a current treatment option.
Trevor Mundel, global head of development at Novartis Pharma, said: “QAB149 has the potential to be recognized as an important once-daily COPD treatment with a rapid onset of action. QAB149 provides COPD patients with greater lung function improvements and reductions in breathlessness compared to other bronchodilators. On approval, our plans are for QAB149 to form the foundation of a new portfolio of potential products designed to improve patients’ respiratory health.”