SAGE - Sage's therapy for Huntington's disease gets orphan drug status in EU

• The European Medicines Agency (EMA) granted orphan drug designation to Sage Therapeutics' ( NASDAQ: SAGE ) medicine  SAGE-718 to treat Huntington's disease (HD).
• The company said SAGE-718 is being developed as an oral therapy for cognitive disorders linked with NMDA receptor dysfunction.
• HD is a rare, genetic disease which causes progressive degeneration of nerve cells in the brain. The disorder impacts a person's functional abilities and also leads to movement, thinking and psychiatric disorders.
• Sage noted that several studies are ongoing with SAGE-718 across disease areas, including phase 2 trials and a phase 3 study in the lead indication of HD-related cognitive impairment.
• In addition, phase 2 trials in mild cognitive impairment (MCI) linked with Parkinson's disease and MCI and mild dementia due to Alzheimer's disease.
• The orphan drug designation in the EU is aimed at therapies for treating or preventing diseases which affect fewer than five in 10,000 people in the EU. The designation provides certain incentives, including 10 years of market exclusivity for the drug, if approved.

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