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Novartis Receives CHMP Positive Opinion For Enerzair Breezhaler

Novartis (NVS) said that the European Medicines Agency's or EMA Committee for Medicinal Products for Human Use or CHMP has adopted a positive opinion recommending the approval of Enerzair Breezhaler as a maintenance treatment of asthma in adult patients not adequately controlled with a maintenance combination of a long-acting beta2-agonist or LABA and a high dose of an inhaled corticosteroid or ICS who experienced one or more asthma exacerbations in the previous year.

The European Commission reviews the CHMP recommendation and usually delivers its final decision in approximately two months.

The CHMP recommendation is based on robust efficacy and safety data from over 3,000 patients with asthma from the Phase III IRIDIUM study, in which IND/GLY/MF demonstrated statistically significant improvements in lung function compared with indacaterol acetate/mometasone furoate.

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