Reuters logo
BRIEF-Alnylam provides pipeline update on Fitusiran and Givosiran investigational RNAI therapeutic programs
September 7, 2017 / 11:21 AM / 3 months ago

BRIEF-Alnylam provides pipeline update on Fitusiran and Givosiran investigational RNAI therapeutic programs

Sept 7 (Reuters) - Alnylam Pharmaceuticals Inc

* Alnylam provides pipeline update on Fitusiran and Givosiran investigational RNAI therapeutic programs

* ‍Suspends Fitusiran dosing due to thrombotic event​

* ‍Aims to resume dosing as soon as possible upon agreement with global regulatory authorities​

* Suspends Fitusiran dosing due to thrombotic event and aims to resume dosing as soon as possible

* ‍New Givosiran phase 3 plan enables potential for NDA filing of interim analysis results at or around year-end 2018​

* ‍Alnylam expects to initiate a phase 3 study of Givosiran in late 2017 with interim analysis data available in mid-2018​

* Suspended dosing in all ongoing Fitusiran studies pending further review of safety event of a risk mitigation strategy

* Reporting fatal thrombotic event in patient with Hemophilia a without inhibitors in phase 2 open-label extension study of fitusiran​

* Recently became aware of fatal serious adverse event that occurred in patient with hemophilia who was receiving Fitusiran in phase 2 ole study​ Source text for Eikon: Further company coverage:

Our Standards:The Thomson Reuters Trust Principles.
0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below