Paediatric epilepsy drug granted Australian orphan status
This article was originally published in Scrip
Executive Summary
The Australian Therapeutic Goods Administration (TGA) has granted orphan status to Sanofi-Aventis's anti-epileptic drug, Frisium (clobazam). Frisium, indicated for the treatment of paediatric refractory epilepsy, was designated on September 14th, making it the 17th drug to be given orphan status by the TGA this year. Others include Roche's Avastin (bevacizumab), for the treatment of malignant glioma; Novartis's Zometa (zoledronic acid) for paediatric patients with severe osteogenesis imperfecta; and Phebra's Midazolam Buccal Liquid (midazolam) for status epilepticus in patients aged up to 19 years.