FDA Approves Onpattro- a Novel RNAi Therapeutic to Treat Polyneuropathy in Adults
Shots:
- Alnylam’s siRNA molecule Onpattro receives FDA approval for fatal genetic disorder polyneuropathy caused by hereditary transthyretin-mediated amyloidosis (hATTR)
- Approval is based on results from Ph III APOLLO study involving 19 countries with the ratio of 2:1 of Onpattro vs Placebo once Q3W for 18mos showing improved QoL
- Alnylam is expected to receive CHMP opinion by Sep’18- with expected regulatory filings in other markets- including Japan in H2’18
Ref: US FDA | Image: Forbes
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