医療従事者の為の最新医療ニュースや様々な情報・ツールを提供する医療総合サイト

Prana Receives First Orphan Drug Designation from the FDA for the Treatment of Multiple System Atrophy

2019年01月31日 PM11:01
このエントリーをはてなブックマークに追加


 

MELBOURNE, Australia & SAN FRANCISCO

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20190131005255/en/

CONTACT

Media
WE Buchan
Scott Newstead
E: snewstead@we-buchan.com
Tp:
+61 429 703 014

Investor Relations
WE Buchan
Rebecca Wilson
E: rwilson@we-buchan.com
Tp:
+61 417 382 391

Related Posts Plugin for WordPress, Blogger...

同じカテゴリーの記事 

  • 印尼生命科学与技术学院在NCRM NICHE 2021上赢得第16届Fujio Cup Quiz大赛;印度Rajalakshmi工程学院获得亚军
  • 辉凌将在ACG 2021上展示基于微生物群的在研活体生物治疗药物RBX2660用于治疗艰难梭菌反复感染和IBD患者的获奖真实临床转归分析
  • ShouTi Secures $100 Million Series B Financing to Accelerate Development of Life-Changing Medicines Fueled by Advanced Computational, Structure-Based Drug Design Platform
  • 硕迪B轮成功融资1亿美元,利用先进的计算和结构药物设计平台加速开发改变患者命运的药物
  • CANbridge Pharmaceuticals CAN103 Investigational New Drug Application Approved in China for Treatment of Gaucher Disease