Merck announced results from two Phase 3 studies investigating fixed-dose combinations of mometasone furoate and formoterol fumarate (MF/F) for the management of asthma, for which a New Drug Application (NDA) is currently under review by the FDA. The first study assessed the efficacy of MF/F 100/10mcg administered via a metered dose inhaler (MDI) twice daily in patients ≥12 years of age with persistent asthma previously treated with low dose inhaled corticosteroids with or without a long-acting beta2-agonist. The second study assessed the efficacy of MF/F 200/10mcg administered via MDI twice daily in patients ≥12 years of age with persistent asthma previously treated with medium dose inhaled corticosteroids with or without a long-acting beta2 agonist.

In both studies, compared with formoterol, MF/F increased time-to-first severe exacerbation and decreased the proportion of patients experiencing severe exacerbations; 16.5% and 30% of patients treated with MF/F experienced severe exacerbations versus 44.7% and 54% of formoterol-treated patients (p<0.001), for Studies 1 and 2, respectively. Compared with mometasone furoate, the mean FEV1 AUC (0-12h) over baseline at week 12 was 4 liter-hours in patients receiving MF/F compared with 2.53 liter-hours in patients receiving mometasone furoate (p=0.001) in Study 1. In Study 2, the mean FEV1 AUC (0-12h) over baseline at week 12 was 3.11 liter-hours in patients receiving MF/F compared with 1.3 liter-hours in patients receiving mometasone furoate (p<0.001).

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