NPS Pharma’s REMS For Gattex Will Face FDA Panel Scrutiny
This article was originally published in The Pink Sheet Daily
Executive Summary
In briefing documents released ahead of the Oct. 16 Gastrointestinal Drugs Advisory Committee review, FDA suggests there is room for improvement in NPS’ communication plan for the short bowel syndrome treatment teduglutide to convey serious risks about malignancy and polyp growth and GI obstruction.
You may also be interested in...
Gattex Review Shows FDA Approach On MedGuides Outside REMS
FDA said a Medication Guide need not be encompassed within NPS Pharma’s proposed Risk Evaluation and Mitigation Strategy for teduglutide due to the extensive interactions between short bowel syndrome patients and their health care providers and the inclusion of other patient-directed materials.
FDA Panel Backs NPS Pharma’s Gattex But Questions Registry Plans
A post-approval registry for the short bowel syndrome drug needs to be rigorously designed and enroll a large proportion of patients in the orphan indication if it is to provide useful information about the drug’s long-term risks, members of FDA Gastrointestinal Drugs Advisory Committee said.
NPS Gattex Launch Preparations Focus On Clinical Care Coordinators
The rare-disease focused company is putting commercial plans in place for its first drug, Gattex, which could launch early next year, and is preparing to file a second NDA in mid-2013, later than expected due to requirements from FDA.