Novartis publishes phase II NVA237 data

Novartis has announced the publication of phase II data for NVA237, a novel once-daily drug candidate for chronic obstructive pulmonary disease.

The company said the trial results showed promising efficacy and tolerability of the compound with onset that is potentially faster than that seen in tiotropium.

According to the study data presented at the annual congress of the European Respiratory Society in Berlin, the compound showed sustained 24-hour bronchodilation.

Its efficacy was comparable to tiotropium, while it was well tolerated with a good overall safety profile and no clinically relevant cardiovascular findings.

Trevor Mundel, head of global development functions at Novartis Pharma, said: “Novartis is committed to the development of innovative, once-daily inhaled products that provide immediate and sustained bronchodilation to relieve the symptoms of airway obstruction.”

He added the company’s extensive late-stage product portfolio of fixed-dose combination and once-daily inhaled products aims to address the currently unmet medical need of patients with respiratory conditions.

Novartis said NVA237 is being assessed as a possible fixed-dose combination with once-daily long-acting beta2-agonist QAB149 currently in phase III of its clinical development.

Last week, Novartis announced the approval of once-yearly Aclasta (zoledronic acid) in the EU as a treatment for osteoporosis in men and the reduction of new fractures in men and postmenopausal women following a broken hip.