19 August 2015 - United Therapeutics Corp. has agreed to sell a voucher meant to speed approval for rare pediatric disease treatments to AbbVie Inc. for $350 million.
United Therapeutics received the voucher when its neuroblastoma treatment Unituxin was approved by the U.S. Food and Drug Administration.
The voucher is part of an incentive program established by the FDA to encourage development of drugs for rare pediatric diseases. The voucher entitles the holder to ask the FDA for priority review of a drug application that would otherwise get a standard review. That could shorten the review process to six months from the standard 10 months.
For more details, go to: http://www.wsj.com/articles/united-therapeutics-sells-priority-review-voucher-to-abbvie-for-350-million-1439981104