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Priority Review Vouchers

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Plegee   Tuesday, 09/18/18 04:23:29 PM
Re: None
Post # of 8026 
Priority Review Vouchers


https://priorityreviewvoucher.org/

Eligibility

To be eligible for a PRV, the drug or vaccine must satisfy the following criteria.

Treat one of the following diseases:
Blinding trachoma
Buruli Ulcer
Chagas (FDA added in 2015)
Chikungunya virus disease (FDA added in 2018)
Cholera
Cryptococcal meningitis (FDA added in 2018)
Dengue
Dracunculiasis
Fascioliasis
Filoviruses (including Ebola) (Congress added in 2014)
Human African trypanosomiasis
Lassa fever (FDA added in 2018)
Leishmaniasis
Leprosy
Lymphatic filariasis
Malaria
Material threat medical countermeasures (Congress added in 2016)
Neurocysticercosis (FDA added in 2015)
Onchocerciasis
Rabies (FDA added in 2018)
Rare pediatric disease (Congress added in 2012)
Schistosomiasis
Soil transmitted helminthiasis
Tuberculosis
Yaws
Zika (Congress added in 2016)
Contain no active ingredient (including any ester or salt of the active ingredient) that has been approved in any other FDA application.
Offer major advances in treatment, or provide treatment where no adequate therapy exists, thus earning priority review on its own merit. In other words, to win a bonus priority review, the treatment must first get its own priority review.
See "Extension to Rare Pediatric" below for eligibility for a pediatric vouchers.

Recipients

The table below includes both the recipient of the voucher and the user of the voucher.
Year Disease Drug Company Price User Drug
1. 2009 Malaria Coartem (artemether/lumefantrine) Novartis Retained Novartis Ilaris (canakinumab)
2. 2012 Tuberculosis Sirturo (bedaquiline) Janssen (JNJ) Retained Janssen (JNJ) Tremfya (guselkumab)
3. 2014 Morquio A syndrome Vimizim (elosulfase alfa) BioMarin $67.5 million Regeneron/Sanofi Praluent (alirocumab)
4. 2014 Leishmaniasis Impavido (miltefosine) Knight $125 million Gilead Odefsey
5. 2015 High-risk neuroblastoma Unituxin (dinutuximab) United Therapeutics $350 million AbbVie
6. 2015 Rare bile acid synthesis disorders Cholbam (cholic acid) Asklepion $245 million Sanofi Combo diabetes
7. 2015 Hereditary orotic aciduria Xuriden (uridine triacetate) Wellstat Sold AstraZeneca
8. 2015 Hypophosphatasia Alexion *
9. 2015 Lysosomal acid lipase (LAL) deficiency Kanuma (sebelipase alfa) Alexion *
10. 2016 Cholera Vaxchora PaxVax *
11. 2016 Duchenne muscular dystrophy Exondys 51 (eteplirsen) Sarepta $125 million Gilead Combo HIV
12. 2016 Spinal muscular atrophy (SMA) Spinraza (nusinersen) Biogen *
13. 2017 Duchenne muscular dystrophy Emflaza (deflazacort) Marathon *
14. 2017 Batten disease Brineura (cerliponase alfa) BioMarin $125 million
15. 2017 Chagas Benznidazole Chemo Research
16. 2017 B-cell acute lymphoblastic leukemia Tisagenlecleucel Novartis
17. 2017 Mucopolysaccharidosis (MPS) VII Mepsevii Ultragenyx $130 million Novartis
18. 2017 Biallelic RPE65 mutation-associated retinal dystrophy Luxturna (voretigene neparvovec-rzyl) Spark $110 million Jazz
19. 2018 X-linked hypophosphatemia (XLH) Crysvita (burosumab-twza) Ultragenyx $80.6 million
20. 2018 Onchocerciasis (river blindness) Moxidectin Medicines Development
21. 2018 Lennox-Gastaut or Dravet syndromes Epidiolex (cannabidiol) GW Research
22. 2018 Smallpox TPOXX (tecovirimat) SIGA
23. 2018 Malaria Krintafel (tafenoquine) GSK and MMV
* Anonymous companies have sold several vouchers, including one sold to ViiV for $130 MM and another to Teva for $150MM in 2017.




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