19 vouchers. all of them accounted for below. 15 in drug development and not label expansions. 9 of those 15 vouchers were granted after p3 top line results were known. 1 other was for a rare disease where deafness was cured, quite an exception. of the other 5, the p3 trials were underway for 4 of them.
only the rare disease deafness cure and Achieve Life Science for vaping cessation have received vouchers prior to p3 being underway. and they, like all the voucher recipients, are still required to run their p3 before the voucher is of any use, unless they are pursuing accelerated approval. and if they are pursuing accelerated approval, they still have to complete the same requirements as everyone else pursuing accelerated approval. the vouchers require standard development pathways to continue to completion.
the voucher only does 1 thing. it eliminates the final 10 month pdufa review and instead makes a decision during what has traditionally been the 60 day preliminary review. the voucher shortens the 8 to 12 month total review into a 1-2 month review, follow the completion of all required trials, and data analysis ans databse lock, and BLA creation.
you can certainly argue that zongertinib voucher was granted BASED ON 1b data and dostarlimab was based on p2. the fact remains they were in p3 when that happened. vouchers aren't being tossed around haphazardly. and regardless, they don't shortcut anything other than the final review period... which is great... it shaves off anywhere from 6 to 11 months at the end of the approval process.
the point is that its not a magic bullet, its not an instant approval, its not a guaranteed approval. its a wild card. and if you have the wild card then you can cash it in after you submit an application for approval, and that cuts your review period by 6 to 11 months.
Regeneron / DB-OTO (Otarmeni):
CURED DEAFNESS in rare disease subpop, voucher granted prior to p3:
Achieve Life Sciences / Cytisinicline
voucher granted after p2, with p3 required
voucher granted last october, p3 not yet recruiting, enrolling 800
Boehringer Ingelheim / Zongertinib
voucher granted while p3 trials were underway
GSK / Dostarlimab
voucher granted after p3 trials were underway
Usona Institute / Psilocybin
voucher granted while p3trials were underway
Disc Medicine / Bitopertin
voucher granted while p3 trials were underway, accelerated approval NDA had been submitted
Vertex / Casgevy (Pediatric)
voucher was granted 1 month prior to p3 top line data release
Compass Pathways / Psilocybin
voucher granted after p3 top line results were announced
Merck / Sac-TMT
voucher granted after p3 top line results were announced
J&J / Tec-Dara
voucher granted after p3 three year outcomes data was released, p3 was functionally completed.
TZIELD’s (teplizumab-mzwv):
voucher granted after p3 trials were completed
Merck KGaA / Pergoveris:
voucher granted after p3 trials were completed
Novo Nordisk / Wegovy
voucher granted after p3 trials were completed
Eli Lilly / Orforglipron
voucher granted after p3 trials were completed
Merck / Enlicitide Decanoate
voucher granted after p3 trials were completed
Cenegermin (Oxervate):
voucher granted for an already approved product, new formulation label expansion
Boehringer Ingelheim / Zongertinib
voucher granted for an already approved product, earlier line of therapy label expansion
Phlow Corp / Ketamine
voucher for manufacturing, not drug development
USAntibiotics / Augmentin XR
voucher for manufacturing, not drug development
only the rare disease deafness cure and Achieve Life Science for vaping cessation have received vouchers prior to p3 being underway. and they, like all the voucher recipients, are still required to run their p3 before the voucher is of any use, unless they are pursuing accelerated approval. and if they are pursuing accelerated approval, they still have to complete the same requirements as everyone else pursuing accelerated approval. the vouchers require standard development pathways to continue to completion.
the voucher only does 1 thing. it eliminates the final 10 month pdufa review and instead makes a decision during what has traditionally been the 60 day preliminary review. the voucher shortens the 8 to 12 month total review into a 1-2 month review, follow the completion of all required trials, and data analysis ans databse lock, and BLA creation.
you can certainly argue that zongertinib voucher was granted BASED ON 1b data and dostarlimab was based on p2. the fact remains they were in p3 when that happened. vouchers aren't being tossed around haphazardly. and regardless, they don't shortcut anything other than the final review period... which is great... it shaves off anywhere from 6 to 11 months at the end of the approval process.
the point is that its not a magic bullet, its not an instant approval, its not a guaranteed approval. its a wild card. and if you have the wild card then you can cash it in after you submit an application for approval, and that cuts your review period by 6 to 11 months.
Regeneron / DB-OTO (Otarmeni):
CURED DEAFNESS in rare disease subpop, voucher granted prior to p3:
Achieve Life Sciences / Cytisinicline
voucher granted after p2, with p3 required
voucher granted last october, p3 not yet recruiting, enrolling 800
Boehringer Ingelheim / Zongertinib
voucher granted while p3 trials were underway
GSK / Dostarlimab
voucher granted after p3 trials were underway
Usona Institute / Psilocybin
voucher granted while p3trials were underway
Disc Medicine / Bitopertin
voucher granted while p3 trials were underway, accelerated approval NDA had been submitted
Vertex / Casgevy (Pediatric)
voucher was granted 1 month prior to p3 top line data release
Compass Pathways / Psilocybin
voucher granted after p3 top line results were announced
Merck / Sac-TMT
voucher granted after p3 top line results were announced
J&J / Tec-Dara
voucher granted after p3 three year outcomes data was released, p3 was functionally completed.
TZIELD’s (teplizumab-mzwv):
voucher granted after p3 trials were completed
Merck KGaA / Pergoveris:
voucher granted after p3 trials were completed
Novo Nordisk / Wegovy
voucher granted after p3 trials were completed
Eli Lilly / Orforglipron
voucher granted after p3 trials were completed
Merck / Enlicitide Decanoate
voucher granted after p3 trials were completed
Cenegermin (Oxervate):
voucher granted for an already approved product, new formulation label expansion
Boehringer Ingelheim / Zongertinib
voucher granted for an already approved product, earlier line of therapy label expansion
Phlow Corp / Ketamine
voucher for manufacturing, not drug development
USAntibiotics / Augmentin XR
voucher for manufacturing, not drug development
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