FDA regulatory review for indacaterol is ongoing.

Novartis received European Commission clearance for its once-daily inhaled COPD therapy, Onbrez® Breezhaler® (indacaterol). Both 150 mcg and 300 mcg doses of the long-acting beta2-adrenergic agonist have been approved as maintenance therapies in adults.

Novartis claims that the drug is the first new EU-sanctioned inhaled compound for treating COPD in seven years. It also states that trials have confirmed OnBrez Breezhaler leads to significantly better lung function than tiotropium, salmeterol, and formoterol and that it has an onset of action of five minutes.

Indacaterol is currently undergoing regulatory review in the U.S. Novartis is working to provide the FDA with additional information on the proposed dosing, which the agency requested in October.

Novartis has three additional investigational treatments in its late clinical-stage COPD portfolio: NVA237 (glycopyrronium bromide) is a novel inhaled long-acting muscarinic antagonist, QVA149 is combination of indacaterol and NVA237, and QMF149 is a combination of indacaterol and mometasone.

In May Novartis and partner, Schering-Plough, (now merged with Merck & Co.) realigned a previously signed collaboration to develop QMF149; mometasone is Schering-Plough’s inhaled corticosteroid. The amended deal gave Novartis exclusive, global rights to the compound, which is administered using Schering-Plough’s Twisthaler® pMDI device for the treatment of COPD and asthma.  In turn, Schering-Plough assumed exclusive rights to develop and commercialize a fixed-combination of mometasone plus the Novartis product, Foradil® (formoterol), another long-acting beta2-adrenergic agonist.

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