Generic Name: lanadelumab
Brand Name: Takhzyro
Manufacturer: Shire Pharma Canada ULC
Indications: Hereditary angioedema, prevention
Manufacturer Requested Reimbursement Criteria1: For routine prevention of attacks of hereditary angioedema (HAE) in adolescents and adults.
Submission Type: New
Project Status: Active
Biosimilar: No
Fee Schedule: Schedule A
- The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.
Key Milestones2 | |
|---|---|
| Call for patient input posted | April 30, 2019 |
| Patient group input closed | June 19, 2019 |
| Clarification: - Patient input submission received from HAE Canada | |
| Patient input summary sent for review to patient input groups | July 24, 2019 |
| Patient group comments on input summary closed | July 31, 2019 |
| Clarification: - Patient input summary feedback received | |
| Submission received | May 29, 2019 |
| Submission accepted for review | June 12, 2019 |
| Review initiated | June 14, 2019 |
| Draft CADTH review report(s) sent to sponsor | September 04, 2019 |
| Comments from sponsor on draft CADTH review report(s) received | September 13, 2019 |
| CADTH review team's comments on draft CADTH review report(s) sent to sponsor | October 03, 2019 |
| Canadian Drug Expert Committee (CDEC) meeting | October 16, 2019 |
| CDEC recommendation sent to sponsor and drug plans | October 28, 2019 To October 30, 2019 |