The announcement in the Federal Register suggests that the FDA will seek advice on whether tofersen can be approved for a specific form of the neurodegenerative disease on the strength of biomarker data, and comes after the regulator had already delayed its review of the drug.
The meeting will be held on 22nd March and look at the data for tofersen as a treatment for superoxide dismutase 1 (SOD1) ALS, focusing mainly on the VALOR trial, which has generated mixed results.
