United Therapeutics Sells Priority Review Voucher to AbbVie for $350 Million
United Therapeutics has agreed to sell its rare pediatric disease priority review voucher to AbbVie for $350 million.
AbbVie did not disclose how it plans to use the voucher, which was issued to United Therapeutics earlier this year when the FDA approved Unituxin (dinutuximab) for high-risk neuroblastoma.
A priority review voucher entitles the holder to an expedited six-month review of a single new drug application or biologics license application, as opposed to 10 months for a standard review.
Sponsors can sell the vouchers without limitation. The FDA awarded the first voucher to BioMarin in February 2014 for its Morquio A Syndrome therapy Vimizim (elosulfase alfa). The following July, Regeneron and Sanofi purchased the voucher from BioMarin for $67.5 million. — Jonathon Shacat