Novartis Revises U.S. Regulatory Strategy For Key Respiratory Drug
This article was originally published in Pharmaceutical Approvals Monthly
The Swiss drug maker says it has agreed with FDA on a Phase III trial design for the combination respiratory drug QVA149 and expects to file in late 2014; plan now calls for testing a twice-daily dose in addition to once-daily.
You may also be interested in...
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.
With largely positive results from four of seven Phase III studies, GlaxoSmithKline and Theravance say they are on track for filing their LABA/LAMA combination UMEC/VI at the end of 2012. But some analysts are wary about regulatory prospects for any LABA-containing drugs and say concerns about dosing could trip up U.S. filing.
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.