Posted by Michael Wonder on 11 May 2017
Efficient trial design — FDA approval of valbenazine for tardive dyskinesia
10 May 2017 - A well-executed development program that addresses both regulatory and clinical requirements is critical for making novel therapeutics available as quickly as possible to patients with unmet medical needs.
In the case of valbenazine, which was recently approved by the U.S. FDA for tardive dyskinesia — a debilitating, iatrogenic movement disorder that primarily affects patients with psychiatric illnesses — a small company pursued thoughtful, efficient trial design and an unusual application of remote assessment in clinical trials. The FDA took an engaged and flexible approach to review, which led to its first approval of a drug for a condition that had previously lacked accepted therapies.
