Novartis Healthcare Private Ltd (NHPL) has launched the Sequadra Inhaler (indacaterol/glycopyrronium) 110mcg/50mcg, a treatment for chronic obstructive pulmonary disease (COPD), which is a fixed dose combination of 2 bronchodilating compounds: indacaterol maleate, a long-acting beta2-adrenergic agonist (LABA) and glycopyrronium bromide, a long-acting anticholinergic (LAMA).
“NHPL is working hard to optimize this important treatment to Indian patients in a timely way,” said Jawed Zia, country president of Novartis India. “Once daily indacaterol/glycopyrronium combination reduces risk of annual rate of exacerbations by 31% compared to the current standard of care (twice-daily salmeterol + fluticasone combination) in patients with moderate-to-severe chronic obstructive pulmonary disease.”
At a press conference, Prof Claus Vogelmeier, Professor of Medicine and Head of Pulmonary Division, Marburg University Hospital, Germany said, “Indacaterol/Glycopyrronium combination will offer these patients a much greater improvement in lung function and health related quality of life. This new therapy will change the management of COPD to the benefit of patients.”
Dr. Ashok Mahashur, Consultant Chest Physician, P.D. Hinduja National Hospital and Medical Research Centre Mumbai, added, “Good to know that combination of indacaterol/glycopyrronium has been launched in India. Based on robust clinical data I feel this combination will be an effective bronchodilator and would reduce exacerbations in COPD patients.”
The combined treatment was created to address COPD in patients who have not responded adequately to treatment with either LABA or LAMA alone. The newly launched inhaler is indicated as a once-a-day, long-term maintenance bronchodilator. Compared to today’s traditionally prescribed treatments, such as SFC 50/500 mcg and open-label tiotropium (18 mcg), clinical studies have successfully demonstrated the combination’s superior ability to improve lung function 2 hours after administration at week 26 of treatment.
Global studies included a sub-population in India, wherein 357 patients were randomized to determine the drug’s safety and efficacy profile, which was found to be consistent with the global population. Two studies involving 191 patients are underway in India, and today, indacaterol/glycopyrronium is approved for use in COPD in more than 76 countries, including those in the EU, Japan, Canada, countries within Latin America and Australia.
In other COPD news, in a new study entitled “Aclidinium bromide and formoterol fumarate as a fixed-dose combination in COPD: pooled analysis of symptoms and exacerbations from two six-month, multicentre, randomized studies (ACLIFORM and AUGMENT),” authors determined the effects of combined aclidinium/formoterol therapy in reducing moderate to severe COPD patients’ symptoms and exacerbation rates. The study was published in the journal Respiratory Research.