EU Commission grants orphan drug status to ZX008 in Lennox Gastaut Syndrome
Release Date: 08-Apr-2017
Zogenix Inc., a leading biopharmaceutical company dedicated to develop therapies to treat orphan and central nervous system (CNS) disorders, declared that European Commission has announced orphan drug designation for the company’s orphan medicinal product, ZX008 (fenfluramine) for effective treatment of Lennox Gastaut Syndrome (LGS), a refractory, debilitating childhood-onset epilepsy. Presently, the drug is being investigated under Phase 3 clinical trial program in Dravet syndrome, intractable, severe epilepsy that begins in infancy.
The EMA orphan drug designation is a status assigned to a medicine intended for use against a rare condition (prevalence of the condition in the European Union must not be more than 5 in 10,000) and allows a pharmaceutical company to benefit from incentives offered by the EU to develop a medicine for the treatment, prevention or diagnosis of a disease that is life threatening or a chronically debilitating rare disease.
“Global Orphan Drug Clinical Pipeline Insight” reports by kuick research gives comprehensive insight on various clinical and non-clinical aspects associated with ongoing clinical trials of 808 orphan designated drugs across the globe. The in-depth clinical insight presented in the report helps the reader to analyze and identify the various stakeholders involved in the clinical development and commercialization of orphan designated drugs in the global market. Currently there are more than 300 orphan designated drugs commercially available in the global market and around 800 drugs in clinical development phase.
