New COPD Candidates Could Get Hung Up On Safety Concerns
This article was originally published in Pharmaceutical Approvals Monthly
FDA is facing several novel candidates for chronic obstructive pulmonary disease in 2013; those products should expect close scrutiny due to past issues with class safety and new signals in clinical trials.
You may also be interested in...
GlaxoSmithKline’s NDA for Breo Ellipta sought a COPD indication without prior approval of the combination product or its individual inhaled corticosteroid and long-acting beta agonist components in asthma. A broad development program with extensive dose finding won over a skeptical FDA.
The company is borrowing a page, and a law firm, from GlaxoSmithKline’s 2009 citizen petition asking FDA to impose conditions on generic Advair.
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.