FDA vouches for United Therapeutics' Unituxin

FDA approved Unituxin dinutuximab ( Ch14.18) from United Therapeutics Corp. (NASDAQ:UTHR) to treat high-risk pediatric neuroblastoma and granted the company a Priority Review voucher through the agency's Rare Pediatric Disease Priority Review Voucher Program.

Unituxin was approved under Priority Review, and has Orphan Drug status in the U.S. to treat the rare pediatric cancer. United spokesperson Andy Fisher said the company plans to launch Unituxin in the U.S. this summer, and will disclose pricing at that time. The drug is under EMA review in the EU, where it also has Orphan designation. ...