1. Pink Sheet

Genzyme’s Lemtrada Experience Offers Lessons for “Breakthrough” Sponsors

 
• By Cole Werble

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.

The “Breakthrough Therapy” program is generating a lot of buzz in its infancy: 85 requests for breakthrough status in the 13 months since the program was created by the FDA Safety & Innovation Act of 2012, with 27 “Breakthrough” designations granted and two approvals already for Breakthrough-designated drugs.

Drug sponsors are jumping at the offer of heightened attention from senior Food & Drug Administration review managers. The added...

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