The US Food and Drug Administration has given the green light to Arcapta Neohaler (indacaterol) for the long term, once-daily maintenance bronchodilator treatment of airflow obstruction in people with COPD, including chronic bronchitis and/or emphysema. The safety and efficacy of Arcapta Neohaler was demonstrated in six clinical trials that included 5,474 patients ages 40 and older with a clinical diagnosis of COPD.
Arcapta Neohaler, is a new molecular entity in the beta2-adrenergic agonist (LABA) class that helps muscles around the airways of the lungs stay relaxed to prevent symptoms of COPD, such as wheezing and breathlessness. It will carry a boxed warning, like all LABAs, that should not be used in patients with asthma, unless used with a long-term asthma control medication.
In March, the FDA's Pulmonary-Allergy Drug Advisory Committee backed indacaterol 75 mcg, voting 13 to four in favour of that dose. However, the panel voted 12 to five against recommending approval of 150 mcg of the drug.
The treatment has also been approved in Japan, where it will be marketed as Onbrez, for the same indication. It is already available in over 60 other countries, including the European Union states.
Analysts believe indacaterol as a monotherapy will only have modest sales but will be lucrative as part of combination treatment currently being evaluated, ie with the inhaled corticosteroid mometasone and also with the long-acting muscarinic antagonist glycopyrronium bromide. Last month, Novartis published late-stage data which suggested that the latter compound, also known as NVA237, has similar efficacy to Boehringer Ingelheim/Pfizer's COPD blockbuster Spiriva (tiotropium).
Links
www.novartis.com
www.fda.gov