Generic Name: migalastat
Brand Name: Galafold
Manufacturer: Amicus Therapeutics
Therapeutic Area: Fabry Disease
Indications: Fabry Disease
Submission Type: Initial
Project Status: Complete
Biosimilar: No
Date Recommendation Issued: January 24, 2018
Recommendation Type: Reimburse with clinical criteria and/or conditions
Fee Schedule: Schedule A
Key Milestones2 | |
|---|---|
| Call for patient input posted3 | May 05, 2017 |
| Patient group input closed3 | June 26, 2017 |
| Clarification: - Patient input submission received | |
| Patient input summary sent for review to patient input groups | July 21, 2017 |
| Patient group comments on input summary closed | July 28, 2017 |
| Clarification: - Patient input summary feedback received | |
| Submission received | June 09, 2017 |
| Submission accepted for review | June 23, 2017 |
| Review initiated | July 05, 2017 |
| Clarification: - Submission temporarily suspended pending receipt of information - Additional information has been received and the temporary suspension of the review has been lifted | |
| Draft CDR review report(s) sent to applicant | October 23, 2017 |
| Comments from applicant on draft CDR review report(s) received | November 01, 2017 |
| Redaction requests from applicant on draft CDR review report(s) received | November 08, 2017 |
| CDR review team's comments on draft CDR review report(s) sent to applicant | December 01, 2017 |
| Canadian Drug Expert Committee (CDEC) meeting | December 13, 2017 |
| CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans | January 03, 2018 |
| Embargo4 period ended and validation of redacted CDR review report(s) received | January 17, 2018 |
| CDEC Final Recommendation issued to applicant and drug plans | January 24, 2018 |
| CDEC Final Recommendation posted5 | January 26, 2018 |
| Final CDR review report(s) and patient input posted5 | February 05, 2018 |