LOL 22 vouchers! 22nd is 2 days old and i'm being attacked for not knowing LOL
there are three of them that weren't label expansions and were granted vouchers prior to p3.
two of the three were for ultra rare disease subpopulations, one with no other treatments available and the other cured deafness.
Partner Therapeutics / Bizengri (zenocutuzumab)
ULTRA RARE disease subpop, for which there was no other treatment, voucher granted prior to p3
voucher granted may 6, approved may 8 - following an april accelerated approval sBLA submission.
this drug has 2 prior approvals, hence the sBLA.
Regeneron / DB-OTO (Otarmeni):
ULTRA RARE disease subpop, cured deafness, voucher granted prior to p3
voucher granted last october, accelerated approval BLA submission december, approved in april
Achieve Life Sciences / Cytisinicline
voucher granted prior to p3, no accelerated approval request so far
voucher granted last october, p3 protocol approved but not yet recruiting
Transcend Therapeutics / Methylone
voucher granted after p3 trials were underway
GSK / Dostarlimab
voucher granted after p3 trials were underway
Revolution Medicines / RMC-6236 (daraxonrasib)
voucher granted after p3 trials were underway
Usona Institute / Psilocybin
voucher granted after p3 trials were underway
Disc Medicine / Bitopertin
voucher granted after 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
Eli Lilly / Orforglipron
voucher granted after p3 trials were completed
Merck / Enlicitide Decanoate
voucher granted after p3 trials were completed
Boehringer Ingelheim / Zongertinib
voucher granted for an already approved product, earlier line of therapy label expansion
voucher granted after p3 trials were underway, based on phase 1b data
J&J / Bedaquiline
voucher granted after p3 trials were completed, restrictions removed label expansion
Novo Nordisk / Wegovy
voucher granted after p3 trials were completed, higher dose label expansion
Cenegermin (Oxervate):
voucher granted for an already approved product, new formulation label expansion
Phlow Corp / Ketamine
voucher for manufacturing, not drug development
USAntibiotics / Augmentin XR
voucher for manufacturing, not drug development
there are three of them that weren't label expansions and were granted vouchers prior to p3.
two of the three were for ultra rare disease subpopulations, one with no other treatments available and the other cured deafness.
Partner Therapeutics / Bizengri (zenocutuzumab)
ULTRA RARE disease subpop, for which there was no other treatment, voucher granted prior to p3
voucher granted may 6, approved may 8 - following an april accelerated approval sBLA submission.
this drug has 2 prior approvals, hence the sBLA.
Regeneron / DB-OTO (Otarmeni):
ULTRA RARE disease subpop, cured deafness, voucher granted prior to p3
voucher granted last october, accelerated approval BLA submission december, approved in april
Achieve Life Sciences / Cytisinicline
voucher granted prior to p3, no accelerated approval request so far
voucher granted last october, p3 protocol approved but not yet recruiting
Transcend Therapeutics / Methylone
voucher granted after p3 trials were underway
GSK / Dostarlimab
voucher granted after p3 trials were underway
Revolution Medicines / RMC-6236 (daraxonrasib)
voucher granted after p3 trials were underway
Usona Institute / Psilocybin
voucher granted after p3 trials were underway
Disc Medicine / Bitopertin
voucher granted after 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
Eli Lilly / Orforglipron
voucher granted after p3 trials were completed
Merck / Enlicitide Decanoate
voucher granted after p3 trials were completed
Boehringer Ingelheim / Zongertinib
voucher granted for an already approved product, earlier line of therapy label expansion
voucher granted after p3 trials were underway, based on phase 1b data
J&J / Bedaquiline
voucher granted after p3 trials were completed, restrictions removed label expansion
Novo Nordisk / Wegovy
voucher granted after p3 trials were completed, higher dose label expansion
Cenegermin (Oxervate):
voucher granted for an already approved product, new formulation label expansion
Phlow Corp / Ketamine
voucher for manufacturing, not drug development
USAntibiotics / Augmentin XR
voucher for manufacturing, not drug development
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