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 (IND/MF). Additionally, we are pleased to bring an innovative sensor and app companion supplied with IND/GLY/MF to patients to help support enhanced adherence.” “Once-daily IND/GLY/MF has the potential to improve asthma control for patients whose lives are still impacted by their disease, despite existing inhaled therapies. “Today’s news is a key milestone in our journey to reimagine asthma care by bringing innovative medicines and a digital companion to patients with uncontrolled asthma,” said Linda Armstrong, MD, Respiratory Development Unit Head, Novartis Pharmaceuticals. This companion will provide patients with inhalation confirmation, medication reminders and access to objective data that can be shared with their physician in order to help them make better therapeutic decisions. If approved, IND/GLY/MF will be the first asthma treatment in the EU that can be prescribed together with a digital companion a Propeller Health sensor and app custom-built for the Breezhaler ® device. IND/GLY/MF will be administered via the dose-confirming Breezhaler ® device, which enables once-daily inhalation using a single inhaler. “In secondary analyses of the Phase III IRIDIUM study statistically significant reductions in moderate-to-severe and severe asthma exacerbation rates were observed with high-dose IND/GLY/MF compared to high-dose salmeterol xinafoate/fluticasone propionate.” “This is an important development for patients with uncontrolled asthma because IND/GLY/MF has been shown to improve lung function and symptoms versus a LABA/ICS standard-of-care,” said Professor Huib Kerstjens, Head, Department of Pulmonology at the University Medical Center Groningen. The European Commission (EC) reviews the CHMP recommendation and usually delivers its final decision in approximately two months. If approved, this will be the first once-daily LABA/long-acting muscarinic antagonist (LAMA)/ICS fixed-dose combination for these patients. 1īasel, Novartis today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Enerzair ® Breezhaler ® (QVM149 indacaterol acetate, glycopyrronium bromide and mometasone furoate ) as a maintenance treatment of asthma in adult patients not adequately controlled with a maintenance combination of a long‑acting beta 2‑agonist (LABA) and a high dose of an inhaled corticosteroid (ICS) who experienced one or more asthma exacerbations in the previous year. In secondary analyses of the Phase III IRIDIUM study, statistically significant improvements in lung function and reductions in moderate-to-severe and severe asthma exacerbation rates were observed with high-dose IND/GLY/MF compared to high-dose Sal/Flu.Decision supported by robust efficacy and safety data from over 3,000 patients with asthma in Phase III IRIDIUM study, in which once-daily IND/GLY/MF demonstrated statistically significant improvements in lung function compared with once-daily IND/MF (QMF149).Digital companion with app and sensor that provide inhalation confirmation, medication reminders and access to objective data to better support therapeutic decisions also covered by positive opinion for Enerzair ® Breezhaler ® (QVM149 IND/GLY/MF).
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