Evgen Gets FDA Orphan Designation
News Aug 27, 2016
Evgen Pharma plc (AIM: EVG) has announced that the US Food & Drug Administration ("FDA") has granted the Company orphan drug designation for the use of stabilised sulforaphane for the treatment of subarachnoid haemorrhage ("SAH"). The Company's SFX-01, a synthetic and stabilised version of sulforaphane, is currently in a Phase II trial, SAS (SFX-01 after Subarachnoid Haemorrhage), in the UK.
The orphan drug designation programme provides orphan status to drugs and biologics for rare diseases or disorders affecting fewer than 200,000 people in the USA. Orphan drug designation gives SFX-01 the potential for US market exclusivity for seven years from the date of marketing approval. SAH is a rare form of stroke in which blood from a ruptured aneurysm enters the protective space around the brain.
The worldwide annual incidence of SAH averages at nine people in every 100,000 and in the USA there are approximately 30,000 cases per year, the significant majority of which are caused by ruptured cerebral aneurysms. SFX-01 represents a potentially new class of drug for the treatment of SAH with a mechanism of action that specifically targets the Nrf-2 pathway. The effect of this is to reduce the oxidative stress and toxicity caused by free haemoglobin from the haemorrhage.
Dr Stephen Franklin, Evgen Pharma's CEO, commented: "The receipt of orphan drug designation in SAH is highly significant for Evgen Pharma and for our clinical programme in SAH, a devastating condition with high unmet clinical need. Evgen's SFX-01, has the potential to represent the first step-change improvement in the treatment of SAH in more than 20 years in that it targets the principal drivers of the delayed vasospasm. Recruitment in our Phase II study of SFX-01 in SAH remains on track and we look forward to the results of the study in due course."