Genzyme’s Lemtrada Experience Offers Lessons for “Breakthrough” Sponsors
This article was originally published in RPM Report
Executive Summary
When it comes to asking for special attention for priority drug development project, sponsors should remember the old adage, “be careful what you ask for, you just might get it.” Inviting FDA review teams to offer more explicit advice on clinical trial designs can be very helpful, but it also carries the implicit obligation to hew more closely to the advice that FDA gives—or face major complications later on.
You may also be interested in...
Genzyme Will Appeal Lemtrada “Complete Response” After FDA Seeks More Trials
Rater-blinded design for multiple sclerosis claim netted an approval in Europe but a rejection by FDA, which was concerned about bias related to open label studies.
Genzyme Will Appeal Lemtrada “Complete Response” After FDA Seeks More Trials
Rater-blinded design for multiple sclerosis claim netted an approval in Europe but a rejection by FDA, which was concerned about bias related to open label studies.
FDA’s “Breakthrough” Exceeds Expectations; Will It Break The Bank?
Drug sponsors are eager to use FDA’s new “breakthrough” therapy development pathway, and the agency is granting designations at a much faster rate than originally expected. But the “all hands on deck” approach required by FDA officials for breakthrough is resource-intensive at a time when the budget sequestration is preventing the agency from accessing all its available user fee funding. Is the popular program at risk?