Posted by Michael Wonder on 04 Nov 2017
Ionis announces submission of marketing authorisation application for inotersen to the European Medicines Agency
3 November 2017 - Inotersen application to be reviewed under EMA accelerated assessment program.
Ionis Pharmaceuticals announced today that the company submitted a marketing authorisation application to the EMA for inotersen, based on the phase 3 NEURO-TTR study in patients with hereditary TTR amyloidosis.
The application for inotersen will be reviewed under the EMA's accelerated assessment program, which is intended to expedite access to drugs that the EMA considers to be of major therapeutic interest.
