Ok so I've done some searching on Uncle Google and Aunty Wiki....(hmmm source of truth, ahem!)
Wiki had a list of priority review vouchers that had been awarded since 2009.
I went through and checked and all of them received FDA Approval - see table below.
https://en.wikipedia.org/wiki/Priority_review
also footnote 2.
https://www.raps.org/regulatory-focus/news-articles/2017/12/regulatory-explainer-everything-you-need-to-know-about-fdas-priority-review-vouchers
I did find one PRV that was used unsuccessfully in 2011. Haven't done enough digging to see if others rejected
http://www.fdalawblog.net/2011/07/priority-review-vouchers-not-much-bang-for-the-buck/
Whilst its an old 2011 article, it said the Priority Review Voucher was unsuccessfully used by Novartis to accelerate the review of its Biologics Licensing Application (BLA) for Ilaris (canakinumab). NB: this was a PR voucher that was awarded to Novartis after their 2009 successful approval of COARTEM (The FDA issued the new PRV as a 'prize'). So Novartis rolled the dice in 2011 on another drug of theirs (not of the FDAs choosing) and FDA rejected it.
But for the most part, as per below, all have been FDA approved.
Program Drug Indication Company FDA Approved 1 Tropical disease Coartem Malaria Novartis Apr-09 2 Tropical disease Sirturo Multi-drug-resistant tuberculosis Janssen Pharmaceutica Dec-12 3 Rare pediatric disease Vimizim Morquio syndrome BioMarin Pharmaceutical Feb-14 4 Tropical disease Impavido Leishmaniasis Knight Therapeutics Mar-14 5 Rare pediatric Unituxin Neuroblastoma United Therapeutics Mar-15 6 Rare pediatric Cholbam Zellweger syndrome Asklepion Pharmaceuticals Mar-15 7 Rare pediatric Xuriden Orotic aciduria Wellstat Therapeutics Oct-15 8 Rare pediatric Strensiq Hypophosphatasia Alexion Pharmaceuticals Oct-15 9 Rare pediatric Kanuma Lysosomal acid lipase deficiency Alexion Feb-16 10 Tropical disease Vaxchora Cholera prevention PaxVax Jun-16 11 Rare pediatric Exondys 51 Duchenne muscular dystrophy Sarepta Therapeutics Sep-16 12 Rare pediatric Spinraza Spinal muscular atrophy Ionis Pharmaceuticals Dec-16 13 Rare pediatric Emflaza Duchenne muscular dystrophy Marathon Pharmaceuticals Feb-17 14 Rare pediatric Brineura Batten disease BioMarin Pharmaceutical Apr-17 15 Tropical disease benznidazole Chagas disease ChemoResearch Aug-17 16 Rare pediatric Kymriah B-ALL Novartis Aug-17 17 Rare pediatric Mepsevii Mucopolysaccharidosis type VII Ultragenyx Nov-17 18 Rare pediatric Luxturna RPE65-mutated retinal dystrophy Spark Therapeutics Dec-17 19 Rare pediatric Crysvita X-linked hypophosphatemia Ultragenyx Apr-18 20 Tropical disease Moxidectin Onchocerciasis Medicines Development for Global Health Jun-18 21 Rare pediatric Epidiolex Lennox-Gastaut syndrome GW Pharmaceuticals Jun-18 22 Material threat countermeasure Tpoxx Smallpox SIGA Technologies Jul-18 23 Tropical disease Krintafel Malaria GlaxoSmithKline Jul-18 24 Rare pediatric Revcovi Adenosine deaminase-SCID Leadiant Biosciences Nov-18 25 Rare pediatric Gamifant Haemophagocytic lymphohistiocytosis Novimmune Nov-18 26 Tropical disease Egaten Fascioliasis Novartis Feb-19 27 Rare pediatric Symdeko F508del cystic fibrosis Vertex Pharmaceuticals Feb-18 28 Tropical disease[9] Dengvaxia Dengue Sanofi May-19 29 Rare pediatric[10] Zolgensma Spinal muscular atrophy AveXis May-19 30 Tropical disease[11] Pretomanid Tuberculosis TB Alliance Aug-19 31 Material threat countermeasure[12] Jynneos Smallpox Bavarian Nordic Sep-19 32 Rare pediatric[13] Trikafta Cystic fibrosis Vertex Pharmaceuticals Oct-19 33 Tropical disease[14] Ervebo Ebola Merck & Co. Dec-19
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