Product overview

Drug action

Ultibro Breezhaler is a combination inhaler containing 2 active ingredients: indacaterol (a long-acting beta2 agonist [LABA]) and glycopyrronium (a long-acting muscarinic antagonist [LAMA]). These are supplied in single-use capsules containing dry powder for inhalation using the Breezhaler. See the summary of product characteristics for Ultibro Breezhaler for more information.

The active ingredients have previously been licensed as single-component inhalers for maintenance treatment of symptoms of chronic obstructive pulmonary disease (COPD). See the summaries of product characteristics for Onbrez Breezhaler and Seebri Breezhaler for more information.

New therapeutic indication

Indacaterol/glycopyrronium (Ultibro Breezhaler; Novartis) received marketing authorisation in Europe in September 2013. It is indicated as a maintenance bronchodilator treatment to relieve symptoms in adults with COPD. The manufacturer declined to share information on the expected UK launch date.

Course and cost

According to the summary of product characteristics for Ultibro Breezhaler, the recommended dose is inhalation of the contents of 1 capsule, once daily using the Breezhaler. Each delivered dose contains 110 micrograms of indacaterol maleate and 50 micrograms of glycopyrronium bromide, which is equivalent to 85 micrograms of indacaterol and 43 micrograms of glycopyrronium.

For comparison, single-component indacaterol (Onbrez Breezhaler) is licensed at daily delivered doses of 120 and 240 micrograms of indacaterol maleate. The licensed daily dose delivered by the single-component glycopyrronium inhaler (Seebri Breezhaler) is 44 micrograms.

The manufacturer declined to share the cost of the indacaterol/glycopyrronium combination inhaler. However, it is expected to be less expensive than the combined cost of the single-component inhalers (indacaterol £29.26, glycopyrronium £27.50 for 30-days' treatment).