On 25th July 2013, the healthcare products company, Novartis, announced that its new, once-daily anticholinergic inhaler, Ultibro Breezhaler, has been backed by the European Union for marketing authorisation. The news comes after the drug was deemed to have demonstrated an acceptable safety profile during its trial phase.
The decision to recommend marketing authorisation, which was made by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), is expected to lead to a new class of long-lasting inhalers being made available to relieve the symptoms of patients suffering from chronic obstructive pulmonary disease (COPD).
Phase III Trials
Developed under the name QVA149, the drug consists of a combination of the bronchodilators indacaterol and glycopyrronium. Indacaterol is a long-acting beta2-adrenergic agonist (LABA), while glycopyrronium falls under the category of long-acting muscarinic antagonists (LAMA). Novartis’ new drug is, therefore, classified as a LABA/LAMA inhaler.
Ultibro Breezhaler was put through several extensive trial phases, including Phase III trials, which involved more than 10,000 patients. One of the studies found the drug to be notably superior to Advair, an inhaler currently marketed by GlaxoSmithKline, in treating COPD. Another study during the trial phase found that Ultibro Breezhaler’s ability to improve lung function is superior to either indacaterol or glycopyrronium, when used on their own.
Furthermore, no evidence was found of any additional adverse reactions, when compared to a placebo.
As a result of the successful Phase III trials, Ultibro Breezhaler became the first fixed-dose inhaler belonging to the LABA/LAMA class to be approved for marketing authorisation by the EU.
According to Datamonitor Healthcare, the LABA/LAMA class of inhalers will become the best-selling treatments amongst sufferers of COPD by the early 2020s. It is a share of the COPD market which, according to experts, will be worth as much as $11bn by 2022.
Ultibro Breezhaler is set to become the first such inhaler to launch in Europe, however, Novartis can anticipate fierce competition in the wider LABA/LAMA inhaler market. GlaxoSmithKline are expected to launch Anoro, a LABA/LAMA inhaler which combines umeclidinium and vilanterol, in the US in early 2014; several months before Ultibro Breezhaler gets its release Stateside.
Yet, despite this competition, the release of Ultibro Breezhaler is expected to significantly strengthen Novartis’ standing within the chronic obstructive pulmonary disease market.