On July 25, 2013, Novartis, a healthcare products company, announced that their new once-daily inhaler, Ultibro Breezhaler, has received marketing authorization from the European Union. This approval came after the drug demonstrated an acceptable safety profile in its trial phase.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended the authorization, paving the way for a new class of long-lasting inhalers to help people with chronic obstructive pulmonary disease (COPD).
Ultibro Breezhaler, developed as QVA149, combines two bronchodilators: indacaterol, a long-acting beta2-adrenergic agonist (LABA), and glycopyrronium, a long-acting muscarinic antagonist (LAMA). This makes it a LABA/LAMA inhaler.
During extensive Phase III trials involving over 10,000 patients, Ultibro Breezhaler was found to be more effective than Advair, an inhaler from GlaxoSmithKline, in treating COPD. One study showed that Ultibro Breezhaler improved lung function better than either indacaterol or glycopyrronium alone. Additionally, no significant adverse reactions were observed compared to a placebo.
Thanks to these successful trials, Ultibro Breezhaler became the first fixed-dose LABA/LAMA inhaler approved for marketing in the EU.
According to Datamonitor Healthcare, LABA/LAMA inhalers are expected to become the top treatment for COPD by the early 2020s, with the market projected to reach $11 billion by 2022.
While Ultibro Breezhaler will be the first such inhaler to launch in Europe, Novartis will face stiff competition in the broader LABA/LAMA market. GlaxoSmithKline plans to release Anoro, a LABA/LAMA inhaler combining umeclidinium and vilanterol, in the US in early 2014, several months before Ultibro Breezhaler hits the US market.
Despite this competition, the launch of Ultibro Breezhaler is expected to significantly boost Novartis’ position in the COPD market.