Merck's Vioxx Gains First-Line Juvenile Rheumatoid Arthritis Indication
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA approval marks first pediatric indication for COX-2 inhibitor class. Pfizer's competing COX-2s Celebrex and Bextra are not being developed for JRA; the Vioxx JRA approval is based on a single non-inferiority trial.
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Vioxx Label To Add Photosensitivity Reactions As Postmarketing Adverse Event
Supplemental NDA revises labeling for COX-2 inhibitor to include photosensitivity reactions. The Vioxx patient package insert will also be revised to include "skin reactions caused by sunlight."
Arcoxia "Coming Soon" Journal Ads Running As User Fee Date Approaches
The ad first appeared in medical journals in early September, well ahead of the Oct. 30 PDUFA date for the COX-2 inhibitor. Merck says the ad does not reflect expectations of a particular FDA review decision but rather is standard industry practice.
Vioxx Label To Add Photosensitivity Reactions As Postmarketing Adverse Event
Supplemental NDA revises labeling for COX-2 inhibitor to include photosensitivity reactions. The Vioxx patient package insert will also be revised to include "skin reactions caused by sunlight."