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mNIS+7: modified Neuropathy Impairment Score+7 composite score
*No statistical analysis performed
Tegsedi 284mg is the same as the study drug inotersen sodium 300mg. TTR: transthyretin; OLE: open label extension
A phase 3, multi-centre, double-blind, randomised, placebo-controlled study. 15-month treatment period.
Patients
Randomly assigned 2:1
Primary end points
Inclusion criteria
Satisfactory completion of treatment in NEURO-TTR.
Patient groups
Patients receiving Tegsedi in NEURO-TTR continued to receive Tegsedi (Tegsedi-Tegsedi group). Patients receiving placebo in NEURO-TTR switched to Tegsedi (placebo-Tegsedi group).
Administration
Patients received 284 mg Tegsedi once weekly via subcutaneous injection for up to 260 weeks (5 years).
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