Alterity Therapeutics Ltd. said the European Commission granted an orphan-drug designation to PBT434 for treating a neurodegenerative disorder called multiple system atrophy.
Multiple system atrophy, or MSA, is a rare, degenerative neurological disorder that affects the body's involuntary functions, including blood pressure, breathing, bladder function and muscle control. It is a form of atypical Parkinson's, where patients present symptoms similar to Parkinson's but do not respond to therapy.
Under the designation, the Australian biotechnology company will have market exclusivity in the EU for 10 years, subject to regulatory approval. Additionally, Alterity will be eligible for benefits such as assistance in developing clinical trials, reduced fees and access to research grants.
The European Medicines Agency's Committee for Orphan Medicinal Products recommended PBT434 for the designation in November 2019.
The U.S. Food and Drug Administration granted orphan-drug designation to PBT434 to treat MSA.