First-in-class once-daily LABA/LAMA inhaler backed by EU committee.
By Natasha Spiller, Analyst
31 July 2013
I am an Analyst at Datamonitor Healthcare. After joining the company in 2012, I have produced analysis across a number o...
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On 25 July 2013, Ultibro Breezhaler (indacaterol maleate/glycopyrronium bromide), developed by Novartis, became the first fixed-dose combination once-daily long-acting beta 2 agonist/long-acting anticholinergic (LABA/LAMA) inhaler to be recommended for marketing authorization in the EU. The positive opinion issued by the Committee for Medicinal Products for Human Use signifies the upcoming entry of a new class of long-acting inhalers in the chronic obstructive pulmonary disease (COPD) market. Datamonitor Healthcare forecasts that the LABA/LAMA drug class will become the best-selling inhaler class for the treatment of COPD in 2021.
Ultibro Breezhaler has been developed through an extensive Phase III clinical trial program involving over 10,000 patients. The ILLUMINATE study demonstrated the significant superiority of Ultibro Breezhaler over the inhaled corticosteroid (ICS)/LABA Advair (salmeterol/fluticasone; GlaxoSmithKline), while the SHINE study demonstrated the significant superiority of the Ultibro Breezhaler in improving lung function compared to the inhaler’s individual components alone.
Ultibro Breezhaler offers patients a substantial advantage with its once-daily dosing formulation. The once-daily formulation will encourage patients currently taking single-formulation LAMAs and LABAs to switch to this new formulation as they seek to simplify their treatment regimens, which is expected to improve compliance and therefore improve outcomes to therapy. Furthermore, the demonstration of superior efficacy to Advair will also encourage patient share to shift from popular ICS/LABA inhalers to Ultibro Breezhaler, boosting commercial prospects of this new inhaler.
However, Novartis is not alone and competition among the LABA/LAMA inhalers will be fierce as these inhalers fight for their share of the COPD market, which Datamonitor Healthcare forecasts to be worth $11bn in 2022 across the US, Japan, and five major EU markets (France, Germany, Italy, Spain, and the UK). Datamonitor Healthcare forecasts that Ultibro Breezhaler will be the first LABA/LAMA inhaler to launch in the EU; however, in the US the inhaler is expected to lose out on first-to-market status to GlaxoSmithKline’s Anoro (umeclidinium/vilanterol), which is currently under regulatory review in the US and is expected to launch in Q1 2014. Following delays, Novartis plans to file for submission in the US for Ultibro Breezhaler by Q4 2014.
Nonetheless, the entry of Ultibro Breezhaler into the COPD market will considerably advance Novartis’s position within the market. Novartis has already developed and globally launched Arcapta Neohaler (indacaterol) and the company will further strengthen its COPD portfolio with its pipeline ICS/LABA inhaler QMF149.
Posted in Cardiovascular.