Arcapta Quality-Of-Life Benefit For Higher Dose Isn't Enough Given Efficacy Data
Executive Summary
Novartis’ experience with its chronic obstructive pulmonary disease drug Arcapta Neohaler is a reminder that while quality-of-life data is nice to have, particularly from a competitive standpoint, it often plays merely a supporting role to clinical efficacy when it comes to product approval.
You may also be interested in...
Novartis Once-Daily COPD Combo Safe, Effective And Ready For Filing – Everywhere But In The U.S.
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 LABA Safety Under Fire, Novartis Addresses Post-Market Studies
Novartis AG is evaluating how to move forward with FDA's extensive new post-marketing safety requirements for long-acting beta agonists as part of its ongoing review of the safety of their use in asthma.
With LABA Safety Under Fire, Novartis Addresses Post-Market Studies
Novartis AG is evaluating how to move forward with FDA's extensive new post-marketing safety requirements for long-acting beta agonists as part of its ongoing review of the safety of their use in asthma.