Prana Receives First Orphan Drug Designation from the FDA for the Treatment of Multiple System Atrophy
January 31 2019 - 9:01AM
Business Wire
Prana Biotechnology Ltd (ASX: PBT, NASDAQ: PRAN) (“Prana” or
“the Company”) has today announced the US Food and Drug
Administration (FDA) has granted Orphan Drug designation for its
lead molecule, PBT434, for the treatment of Multiple System Atrophy
(MSA). This is the first time the FDA has granted orphan
designation to a drug for the treatment of MSA.
Orphan Drug designation by the FDA entitles Prana to seven years
of market exclusivity for the use of PBT434 in the treatment of MSA
and qualifies the sponsor of the drug for various development
incentives of the Orphan Drug Act, including tax credits for
qualified clinical testing.
Prana’s successful application was based on the proposed use of
PBT434 as a treatment for MSA, including the medical and scientific
rationale. The application articulated how PBT434 prevents
α-synuclein accumulation, preserves neurons, and improves motor
function in a widely accepted animal model of MSA. Alpha-synuclein
is of great interest because aggregated forms of the protein are a
pathological hallmark of Parkinsonian conditions, including MSA,
and it represents a recognised therapeutic target by the scientific
community.
“We are pleased that the FDA has acknowledged the importance of
PBT434 as a potential treatment for MSA. This recognition, in
conjunction with the recent investment from Life Biosciences,
positions us strongly to accelerate the development of PBT434 for
this devastating condition,” said Dr David Stamler, Chief Medical
Officer.
Prana has identified a clear unmet medical need with no approved
treatments specifically for MSA. Prana is conducting a Phase 1
clinical trial of PBT434 and expects it to be completed this
year.
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