COPD Drug Dose Selection May Face Greater Scrutiny In Arcapta’s Wake
FDA’s lingering concerns about the appropriate dose for Novartis’ chronic obstructive pulmonary disease therapy Arcapta Neohaler (indacaterol) suggest the agency will take a harder line on dosing data requirements for new COPD treatments, particularly when they have not first been approved in asthma.
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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.
Novartis released results from “an unprecedented package of data” to be filed with European regulators for its novel once-daily dual bronchodilator combination of the LABA indacaterol and the LAMA NVA237 (glycopyrronium) for COPD at the European Respiratory Society Congress, but FDA has already made clear that it wants to see trials with once- and twice-daily dosing at lower strengths than those tried in the European program, and those studies have yet to launch.
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.