Glaxo Wellcome Lotronex
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
FDA's proposal to include black box warning on constipation in alosetron labeling is countered by Glaxo Wellcome at the June 27 FDA Gastronintestinal Drugs Advisory Committee with a proposal for bold, underlined warnings on constipation and ischemic colitis. Glaxo also proposed contraindicating Lotronex in patients with a history of chronic or severe constipation. The drug is indicated for use in women with diarrhea-predominant irritable bowel syndrome, not constipation-predominant IBS or symptoms alternating between the two. Committee members questioned whether approved labeling goes "far enough" in preventing use of the agent by patients with alternating symptoms. The committee recommended that studies be conducted on risk factors, such as smoking and use of oral contraceptives. Several members agreed with FDA that Lotronex should provide a MedGuide, an FDA-approved patient information inser
You may also be interested in...
Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa
The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.
Partisan Politics Returns To US FDA Congressional Oversight
The US FDA has stood out as an agency that tends to draw broad bipartisan support amid a generally rancorous and divided Congress. A House hearing, however, may be a sign that those days are over.
GLP-1 Coverage Restrictions In Medicare Part D Surge As Demand For Obesity Drugs Grows
A major shift from unfettered coverage to prior authorizations was recorded by MMIT over the past year for the leading GLP-1/GIP agonist diabetes drugs. Public interest in using the drugs off label for weight loss drove the change.