drugset / Press release

Ionis Announces Submission of Marketing Authorization Application for Inotersen to the European Medicines Agency

2017-11-03 · Ionis Pharmaceuticals · original ionis.com ↗

Inotersen MAA to be reviewed under EMA Accelerated Assessment program CARLSBAD, Calif., Nov. 3, 2017 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) announced today that the company submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for inotersen, based on the phase 3 NEURO-TTR study in patients with hereditary TTR amyloidosis (hATTR). The MAA 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.

The release as fetched from its publisher. ionis.com ↗