Avicena's HD-02 granted US orphan status

Palo Alto, California, USA-based biotechnology firm Avicena says that the Food and Drug Administration has granted orphan drug designation to HD-02, its proprietary drug candidate for the treatment of Huntington's disease.

The company noted that recent data, published in the journal Neurology, showed that the drug was safe and well-tolerated by patients on 8g/day, while resulting in elevated serum and brain levels of creatine and reduced biomarkers of oxidative damamge.

Orphan designation entitles Avicena to a range of benefits including seven-year marketing exclusivity following approval, tax credits for clinical research, reduced filing fees, grants for further R&D and assistance with the review of clinical trial protocols.