Novartis Finally Wins Arcapta Approval, Having Lost Battle On Desired Dose
This article was originally published in The Pink Sheet Daily
Bronchodilator is approved for COPD at a 75 mcg dose, compared to 150 mcg and 300 mcg in Europe. Label nods to quality-of-life data.
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The lead LAMA/LABA combination for COPD will be reviewed at the Sept. 10 session of the Pulmonary-Allergy Drugs Advisory Committee.
New drugs are hitting the COPD market, but largely offer incremental benefit over gold standards Advair and Spiriva. Given the modest efficacy improvement and increasingly price sensitive patients and payers, new higher-priced products may find the commercial market a challenge.
Boehringer Ingelheim’s long acting beta-adrenergic agonist for chronic obstructive pulmonary disease will have to overcome LABA class issues in asthma at an advisory committee in January. The drug is up first for single-agent approval, but it is meant to be half of a combination therapy with the blockbuster treatment Spiriva.