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Review Of Reviews: Drug Review Profiles 2013

Executive Summary

Pharmaceutical Approvals Monthly’s Drug Review Profile stories from 2013.

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Ariad Took Dismissive View Of CV Events In Iclusig Labeling Proposals

FDA rejected two of the sponsor’s labeling proposals because they failed to adequately address safety issues seen in the PACE trial. Ariad apparently preferred to quantify in labeling only treatment-emergent adverse events that investigators attributed to ponatinib – an approach FDA disdains for single-arm studies.

The Magnitude Matters: GSK Approvals Show How To Use PFS After Other Drugs Show Survival

Submitting an NDA based on progression-free survival when other drugs for the indication have been approved on the basis of overall survival benefits is a risky proposition, but GlaxoSmithKline was confident the magnitude of Mekinist and Tafinlar’s PFS effect in metastatic melanoma would make the findings clinically relevant.

Breo Inverts Traditional Path To COPD Indication For LABA Combinations

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.

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