Biohaven secures orphan drug status for verdiperstat in MSA treatment

Biohaven secures orphan drug status for verdiperstat in MSA treatment

Connecticut-based Biohaven Pharmaceutical has received a significant regulatory boost, with the US FDA granting orphan drug designation for its investigational drug verdiperstat for treating multiple system atrophy (MSA). This rare and debilitating neurodegenerative disease has long been a target for pharmaceutical companies seeking breakthroughs in treatment, and verdiperstat’s designation underscores its potential as a game-changer […]

Prana Biotechnology secures FDA orphan drug status for PBT434 to treat multiple system atrophy

Prana Biotechnology secures FDA orphan drug status for PBT434 to treat multiple system atrophy

In a significant milestone, Prana Biotechnology, an Australian biotech company, has obtained Orphan Drug designation from the FDA for PBT434, its lead molecule aimed at treating Multiple System Atrophy (MSA), a rare and degenerative neurological disease. This designation offers Prana Biotechnology substantial regulatory advantages, such as seven years of market exclusivity and access to tax […]