Chronic Fatigue Syndrome Presents Challenging Test Case For PDUFA V Program
This article was originally published in The Pink Sheet Daily
Executive Summary
The first of 20 patient-focused drug development meetings kicks off April 25 with a workshop on CFS and myalgic encephalomyelitis; FDA can expect to hear extensive patient testimony about an array of symptoms and co-morbid conditions, as well as some dissension within the patient community over how the two conditions should be viewed.
You may also be interested in...
Patient Feedback Pioneers: Chronic Fatigue Advocates Prepare for First PDUFA V Meeting
FDA has selected CFS/ME as the first topic for the PDUFA V patient-centered drug development initiative. The lessons learned from this session will inform future work on patient engagement in drug development both for FDA—and for patient advocates.
FDA Uses AdComm Process To Shine Light On Ampligen’s Troubled Development
December’s Arthritis Advisory Committee review of Hemispherx’s drug provided FDA with the first public opportunity to explain in detail why the chronic fatigue syndrome drug, in development for almost 25 years, has not passed regulatory muster to date.
Accelerated Approval Is US FDA Panel’s Preferred Path For Biogen/Ionis’s Tofersen In ALS
Advisory committee unanimously concludes that the reduction in plasma neurofilament light chain concentration is reasonably likely to predict clinical benefit in SOD1-ALS, but majority of panelists say convincing evidence of efficacy to support regular approval has not been demonstrated.