Reuters logo
BRIEF-Acorda provides update on tozadenant development program
November 15, 2017 / 12:15 PM / a month ago

BRIEF-Acorda provides update on tozadenant development program

Nov 15 (Reuters) - Acorda Therapeutics Inc:

* Provides update on tozadenant development program

* Identified cases of agranulocytosis, possibly drug-related, in some cases associated with sepsis and death​

* Discussions with FDA and DSMB ongoing​

* Increased blood cell count monitoring to weekly in ongoing Phase 3 program for tozadenant​

* Increased frequency of blood cell count monitoring for participants to weekly in phase 3 program of tozadenant for Parkinson’s Disease​

* Paused new enrollment in long-term safety studies, pending further discussion with independent data safety monitoring board, FDA​

* Including previously conducted Phase 2B study, about 890 patients have been exposed to tozadenant and 234 have been exposed to placebo​

* Contingent on input from DSMB and FDA, continue to expect to report efficacy and safety results of double-blind phase 3 study in Q1 of 2018​

* There have been seven cases of sepsis, all in tozadenant groups, five of which were fatal​

* Four sepsis cases were associated with agranulocytosis in tozadenant groups​ Source text for Eikon: Further company coverage:

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