Tuesday, September 18, 2018 4:23:29 PM
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.
Recent CLRB News
- Iopofosine I 131 Featured in Two Separate Presentations at 12th International Workshop on Waldenstrom’s Macroglobulinemia • GlobeNewswire Inc. • 08/26/2024 10:40:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/23/2024 09:15:38 PM
- Cellectar to Restate Previously Issued Financial Statements – Company Announces Receipt of Expected Delinquency Notification Letter from Nasdaq • GlobeNewswire Inc. • 08/23/2024 09:00:00 PM
- Form SC 13G/A - Statement of Beneficial Ownership by Certain Investors: [Amend] • Edgar (US Regulatory) • 08/14/2024 11:15:55 PM
- Form NT 10-Q - Notification of inability to timely file Form 10-Q or 10-QSB • Edgar (US Regulatory) • 08/14/2024 09:00:27 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/13/2024 10:45:19 AM
- Cellectar Biosciences Reports Financial Results for Q2 2024 and Provides a Corporate Update • GlobeNewswire Inc. • 08/13/2024 10:40:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/09/2024 09:00:47 PM
- UPDATE -- Cellectar Biosciences to Announce Second Quarter Financial Results and Host a Conference Call on Tuesday, August 13, 2024 • GlobeNewswire Inc. • 08/08/2024 09:15:14 PM
- Cellectar Biosciences to Announce First Quarter Financial Results and Host a Conference Call on Tuesday, August 13, 2024 • GlobeNewswire Inc. • 08/08/2024 08:05:00 PM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 07/24/2024 04:15:06 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/23/2024 10:45:24 AM
- Cellectar Biosciences’ Iopofosine I 131 Exceeds Primary Endpoint in Waldenstrom’s Macroglobulinemia Pivotal Study with 78% of Major Response Patients Remaining Progression Free at 18 Months • GlobeNewswire Inc. • 07/23/2024 10:40:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/22/2024 10:45:16 AM
- Cellectar Biosciences Announces Exercise of Tranche B Warrants and Purchase of New Warrants for Approximately $19.4 million with the Potential to Raise Up to an Additional $73.3 Million • GlobeNewswire Inc. • 07/22/2024 10:40:00 AM
- Form SC 13G/A - Statement of Beneficial Ownership by Certain Investors: [Amend] • Edgar (US Regulatory) • 07/11/2024 09:37:40 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/11/2024 09:15:21 PM
- Cellectar Biosciences to Host Key Opinion Leader Event to Review the Full Results from Its CLOVER WaM Pivotal Trial and Waldenstrom’s Macroglobulinemia Market Landscape • GlobeNewswire Inc. • 06/27/2024 10:40:00 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/18/2024 09:04:49 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/18/2024 09:04:06 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/18/2024 09:03:28 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/18/2024 09:02:59 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/18/2024 09:01:59 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/18/2024 09:01:29 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/18/2024 09:00:17 PM
FEATURED Cannabix Technologies and Omega Laboratories Inc. Advance Marijuana Breathalyzer Technology - Dr. Bruce Goldberger to Present at Society of Forensic Toxicologists Conference • Sep 24, 2024 8:50 AM
FEATURED Integrated Ventures, Inc Announces Strategic Partnership For GLP-1 (Semaglutide) Procurement Through MedWell USA, LLC. • Sep 24, 2024 8:45 AM
Avant Technologies Accelerates Creation of AI-Powered Platform to Revolutionize Patient Care • AVAI • Sep 24, 2024 8:00 AM
VHAI - Vocodia Partners with Leading Political Super PACs to Revolutionize Fundraising Efforts • VHAI • Sep 19, 2024 11:48 AM
Dear Cashmere Group Holding Co. AKA Swifty Global Signs Binding Letter of Intent to be Acquired by Signing Day Sports • DRCR • Sep 19, 2024 10:26 AM
HealthLynked Launches Virtual Urgent Care Through Partnership with Lyric Health. • HLYK • Sep 19, 2024 8:00 AM