Pfizer: receives fast track designation from FDA
(CercleFinance.com) - Pfizer announced today that its experimental gene therapy candidate (PF-06939926), which is being developed to treat Duchenne Muscular Dystrophy (DMD) has received Fast Track designation from the FDA.
This process facilitates drug development and accelerates the examination of new drugs to treat or prevent serious conditions, thereby meeting an unsatisfied medical need.
PF-06939926 is currently being evaluated to determine the safety and effectiveness of this gene therapy in boys suffering from DMD.
This designation was granted based on data from the Phase 1b study which indicated that intravenous administration of PF-06939926 was well tolerated during the infusion period and the expression levels of dystrophin were maintained over a 12-month period.
Copyright (c) 2020 CercleFinance.com. All rights reserved.
This process facilitates drug development and accelerates the examination of new drugs to treat or prevent serious conditions, thereby meeting an unsatisfied medical need.
PF-06939926 is currently being evaluated to determine the safety and effectiveness of this gene therapy in boys suffering from DMD.
This designation was granted based on data from the Phase 1b study which indicated that intravenous administration of PF-06939926 was well tolerated during the infusion period and the expression levels of dystrophin were maintained over a 12-month period.
Copyright (c) 2020 CercleFinance.com. All rights reserved.