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abobotulinumtoxinA

Last Updated: November 22, 2017
Result type: Reports
Project Number: SR0517-000
Product Line: Common Drug Review

Generic Name: abobotulinumtoxinA

Brand Name: Dysport Therapeutic

Manufacturer: IPSEN Biopharmaceuticals Canada, Inc.

Indications: Upper limb spasticity

Submission Type: New Indication

Project Status: Complete

Biosimilar: No

Date Recommendation Issued: October 24, 2017

Recommendation Type: Reimburse with clinical criteria and/or conditions

Fee Schedule1: Schedule B

Key Milestones2

Call for patient input posted3 March 17, 2017
Patient group input closed3 May 08, 2017
Clarification:

-Patient input submission received

Patient input summary sent for review to patient input groups May 15, 2017
Patient group comments on input summary closed May 23, 2017
Clarification:

-Patient input summary feedback received

Submission received April 24, 2017
Submission accepted for review May 08, 2017
Review initiated May 09, 2017
Draft CDR review report(s) sent to applicant July 31, 2017
Comments from applicant on draft CDR review report(s) received August 10, 2017
Redaction requests from applicant on draft CDR review report(s) received August 17, 2017
CDR review team's comments on draft CDR review report(s) sent to applicant September 08, 2017
Canadian Drug Expert Committee (CDEC) meeting September 20, 2017
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans October 02, 2017
Embargo4 period ended and validation of redacted CDR review report(s) received October 17, 2017
CDEC Final Recommendation issued to applicant and drug plans October 24, 2017
CDEC Final Recommendation posted5 October 26, 2017
Final CDR review report(s) and patient input posted5 November 16, 2017

Tags

nervous system, botulinum toxins, type a, muscle hypertonia, muscle hypotonia, upper extremity, botulinum neurotoxin; botulinum neurotoxins; botulinum toxin a; Spasticity; upper extremities; upper limbs