Novartis's COPD combo gets CHMP nod
This article was originally published in Scrip
The European Medicines Agency's Committee for Medicinal Products for Human Use has issued positive opinions for Novartis's chronic lung disease product Ultibro/Xoterna Breezhaler. It combines the long-acting muscarinic antagonist glycopyrronium bromide with the fast-acting beta-2 agonist indacaterol.
Indication and dosing details
The product (indacaterol 85mcg/glycopyrronium 43mcg delivered dose, equivalent to 110mcg/50mcg metered dose per capsule) has been recommended for approval as a once-daily maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Panel's summary of benefit
The benefits are its ability to relieve symptoms in adult patients with COPD.
Side-effect details
The most common side-effects are are the beta-adrenergic and anticholinergic symptoms related to the individual components of the combination.
Market size
Analysts have predicted the product could reach peak global sales of $1.2-1.5bn.
Competition
The key pipeline once-a-day fixed-dose inhalers emerging from big pharma pipelines are GlaxoSmithKline's Anoro (umeclidinium/vilanterol), Boehringer Ingelheim's olodaterol/tiotropium and this product of Novartis's, formerly known as QVA149. Novartis is in the lead in the race to market in the EU, although GSK is ahead in the US.
Next steps
A pharmacovigilance plan for the product will be implemented as part of the marketing authorization.
Related stories
Novartis files COPD combo drug in EU (scripintelligence.com, 26 October 2012).