Data schmata! It’s the Biogen way.
Biogen throws itself back into muddled data arguments with more details on its antisense ALS drug – Endpoints News
Biogen throws itself back into muddled data arguments with more details on its antisense ALS drug
With a highly watched FDA decision deadline coming in late January, Biogen and Ionis dropped the full data on the Phase III study of their ALS drug tofersen in the New England Journal of Medicine on Wednesday.
Biogen is looking for approval for tofersen in a very small subset of ALS patients — some 2%, according to the paper — who have a SOD1 gene mutation, which has previously been linked to ALS. Tofersen is meant to reduce levels of mutant SOD1 proteins.
In the “fast-progressing” subgroup of the Phase III trial, the drug failed to significantly reduce functional and neurological decline in ALS patients with that mutation, Biogen previously announced. However, it is gunning for approval on data that show the drug reduced levels of neurofilament, which has been tied to the progression of a number of neurodegenerative diseases, though isn’t an established biomarker.
Biogen throws itself back into muddled data arguments with more details on its antisense ALS drug – Endpoints News
Biogen throws itself back into muddled data arguments with more details on its antisense ALS drug
With a highly watched FDA decision deadline coming in late January, Biogen and Ionis dropped the full data on the Phase III study of their ALS drug tofersen in the New England Journal of Medicine on Wednesday.
Biogen is looking for approval for tofersen in a very small subset of ALS patients — some 2%, according to the paper — who have a SOD1 gene mutation, which has previously been linked to ALS. Tofersen is meant to reduce levels of mutant SOD1 proteins.
In the “fast-progressing” subgroup of the Phase III trial, the drug failed to significantly reduce functional and neurological decline in ALS patients with that mutation, Biogen previously announced. However, it is gunning for approval on data that show the drug reduced levels of neurofilament, which has been tied to the progression of a number of neurodegenerative diseases, though isn’t an established biomarker.