Eisai rufinamide NDA
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Eisai is seeking two indications for its anti-epileptic rufinamide: adjunctive therapy for Lennox-Gastaut syndrome in children ages four and up and adjunctive therapy for partial-onset seizures with and without secondary generalization in adults and adolescents ages 12 and over. The firm submitted the NDA for the triazole derivative Sept. 9, putting a standard review deadline at July 9, 2006. The two pivotal trials supporting the indications were conducted by innovator Novartis. Rufinamide is "structurally distinct from currently approved [anti-epileptic drugs]," Eisai notes. The agent was granted orphan status for Lennox-Gastaut in October 2004...
You may also be interested in...
Eisai Rufinamide Electronic Resubmission Aims To Make NDA More Accessible
Formatting issues with Eisai's original rufinamide anti-epilepsy NDA could result in a more than two-month delay in approval
Cochlear’s Osia System Receives Expanded FDA Clearance For Use In Younger Children
Kids ages 5 and up now can benefit from Cochlear’s Osia implant and sound processor, indicated for hearing loss, mixed hearing loss and single-sided sensorineural deafness.
MAISI: Navigating The 'Valley Of Death' In Medtech Research Translation
Translating research from proof of concept to clinical investigations is a difficult hurdle to overcome. To succeed, researchers need to design their technology for industrial standard manufacturing early on, Anne Vanhoestenberghe, director for the Manufacture of Active Implants and Surgical Instruments (MAISI), told Medtech Insight.