In brief: Ionis seeks EU marketing authorisation for antisense drug

In brief: Ionis seeks EU marketing authorisation for antisense drug
Ionis HQ

California’s Ionis Pharmaceuticals has submitted a marketing authorisation application to the European Medicines Agency (EMA) for inotersen.

The application was backed up by the phase 3 NEURO-TTR study in patients with hereditary TTR amyloidosis (hATTR).

It 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.

Inotersen is an antisense drug designed to reduce the production of transthyretin – or TTR – to treat patients with TTR amyloidosis (ATTR), a severe, rare and fatal disease.