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Ultibro Breezhaler, Ulunar Breezhaler, indacaterol/glycopyrronium bromide (QVA149)

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Company Novartis AG
DescriptionFixed-dose combination of glycopyrronium bromide (NVA237), an inhaled long-acting muscarinic receptor antagonist (LAMA), and indacaterol, a long-acting adrenergic receptor beta 2 agonist (LABA)
Molecular Target Adrenergic receptor beta 2 (ADRB2) ; Muscarinic receptor
Mechanism of ActionAdrenergic receptor beta 2 (ADRB2) agonist; Muscarinic receptor antagonist
Therapeutic ModalitySmall molecule: Combination
Latest Stage of DevelopmentMarketed
Standard IndicationChronic obstructive pulmonary disease (COPD)
Indication DetailsMaintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD); Treat chronic obstructive pulmonary disease (COPD)
Regulatory Designation U.S. - Standard Review (Maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD));
EU - Standard Review (Maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD));
Japan - Standard Review (Maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD))
Partner Pfizer Inc.; Sosei Group Corp.; Vectura Group plc

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