Prana Gets FDA Orphan Drug Designation For PBT2 For Huntington Disease

(RTTNews) - Prana Biotechnology Limited (PRAN, PBT.AX) said that the US Food and Drug Administration or FDA has granted Orphan Drug designation to PBT2 for the treatment of Huntington Disease.

The company said it will also be applying for Orphan Drug designation in Europe and other jurisdictions.

Huntington disease is a neurodegenerativegenetic disorder that affects muscle coordination and leads to cognitive decline and behavioral symptoms. More than 30,000 people in the US have Huntington disease and there are currently no treatments for the cognition or executive function symptoms of the disease.

Prana noted that it is preparing its Post Phase 2 Trial dossier for submission to the FDA to commence discussions on the next development steps for PBT2.

Orphan drug designation is granted by the FDA to promote the development of drugs for diseases affecting less than 200,000 people in the United States. Orphan drug designation entitles Prana to seven years of market exclusivity for the use of PBT2 in the treatment of Huntington disease; protocol assistance by the FDA to optimize drug development in the preparation of a dossier that will meet regulatory requirements; and reduced fees associated with applying for market approval.