Novartis has launched its once-daily Arcapta Neohaler product in the US for maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).
The indacaterol-based product – formerly known as QAB149 – was approved by the FDA last July and is claimed to be the first once-daily, 24-hour long-acting beta2-agonist (LABA) class to be approved in the US for this indication.
Andre Wyss, president of Novartis' US subsidiary, said: "The launch of Arcapta Neohaler is a significant milestone as we continue to establish a strong respiratory presence in the US market."
While Arcapta Neohaler is expected to have fairly modest sales as a monotherapy, Novartis is developing combination products with the inhaled corticosteroid mometasone and long-acting muscarinic agonist (LAMA) glycopyrronium bromide and analysts have predicted that these could drive franchise sales up to the blockbuster level at peak.
Currently, the top-selling drugs for COPD are GlaxoSmithKline's beta agonist and corticosteroid combination Advair/Seretide/Adoair (salmeterol/fluticasone) and Boehringer Ingelheim/Pfizer's muscarinic antagonist Spiriva (tiotropium) with sales of around $8bn (including asthma sales) and $4bn respectively last year.
Indacaterol was first approved in 2009 in the EU as the Onbrez Breezhaler, and under that brand has achieved a little over $100m in sales last year.
The situation has been somewhat different in the US though, with the FDA blocking its approval in 2009 on safety concerns.
Then in March 2011 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 a 150mcg dose of the drug saying its efficacy was equivalent to the lower dose.
Novartis said in a statement that the safety and efficacy of Arcapta Neohaler has been demonstrated in six clinical trials that included 5,474 patients ages 40 and older with a clinical diagnosis of COPD, including more than 2,500 who received Arcapta Neohaler for at least 12 weeks at doses of 75mcg or higher.
There are around 14m people in the US living with COPD, according to the company.