Post-Authorization Activity Table (PAAT) for Evusheld
Updated: 2024-03-22
The following table describes post-authorization activity for Evusheld, a product which contains the medicinal ingredients tixagevimab and cilgavimab. For more information on the type of information found in PAATs, please refer to the Frequently Asked Questions: Summary Basis of Decision (SBD) Project: Phase II and to the List of abbreviations found in Post-Authorization Activity Tables (PAATs).
For additional information about the drug submission process, refer to the Guidance Document: The Management of Drug Submissions and Applications.
Drug Identification Number (DIN):
DIN 02526271 - 150 mg/1.5 mL tixagevimab, solution, and 150 mg/1.5 mL cilgavimab, solution, co-packaged, intramuscular administration
Post-Authorization Activity Table (PAAT)
| Activity/submission type, control number | Date submitted | Decision and date | Summary of activities |
|---|---|---|---|
| SNDS # 279489 | 2023-09-27 | Issued NOC 2024-02-22 | Submission filed as a Level II – Supplement (Safety) in response to commitments made as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. The submission was filed to update the PM with safety information from final clinical study reports for the PROVENT, STORM CHASER, and TACKLE studies, and the final population pharmacokinetics analysis report. The submission was reviewed and considered acceptable. As a result of the SNDS, modifications were made to the Indications (Geriatrics), Warnings and Precautions, Adverse Reactions, Clinical Pharmacology, Clinical Trials, and Microbiology sections of the PM. An NOC was issued. |
| DIN 02526271 reported as dormant | Not applicable | 2024-01-10 | The manufacturer reported the DIN as dormant as per section C.01.014.71 and subsection C.01.014.5(1)(a)(ii) of the Food and Drug Regulations. |
|
Risk Management Plan update Control # 277310 |
2023-07-18 | Review completed 2023-11-02 | The updated Core Risk Management Plan (RMP) version 5 and the Canadian Addendum succession 4 version 1 were filed as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. The information was reviewed and found acceptable. No further action was required. |
| PBRER # 277342 | 2023-07-19 | Review completed 2023-10-27 | Submission filed in response to commitments made as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. PBRER #3 for the period 2022-11-14 to 2023-05-13. The information was reviewed and found acceptable. No further action was required. |
| NC # 277416 | 2023-07-21 | Issued NOL 2023-09-11 | Submission filed as a Level II (90 day) Notifiable Change (Moderate Quality Changes) to extend the shelf life of the drug substances. The submission was reviewed and considered acceptable, and an NOL was issued. |
| PBRER # 271339 | 2023-01-12 | Review completed 2023-06-27 | Submission filed in response to commitments made as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. PBRER #2 for the period 2022-05-14 to 2022-11-13. The information was reviewed and found acceptable. No further action was required. |
| SNDS # 273952 | 2023-04-03 | Issued NOC 2023-05-30 | Submission filed as a Level II – Supplement (Safety) to update the PM with neutralizing activity of Evusheld against the Omicron XBB.1.5 variant. The submission was reviewed and considered acceptable. As a result of the SNDS, modifications were made to the Microbiology section of the PM. An NOC was issued. |
| NC # 273300 | 2023-03-14 | Issued NOL 2023-05-15 | Submission filed as a Level II (90 day) Notifiable Change (Moderate Quality Changes) to extend the shelf life of the drug product. The submission was reviewed and considered acceptable, and an NOL was issued. |
| SNDS # 271993 | 2023-02-01 | Issued NOC 2023-03-09 |
Submission filed as a Level II – Supplement (Safety) to update the PM with a change in language for hypersensitivity and anaphylaxis. The submission was reviewed and considered acceptable. As a result of the SNDS, modifications were made to the Warnings and Precautions, and Adverse Reactions sections of the PM. An NOC was issued. |
| PBRER # 266241 | 2022-07-21 | Review completed 2023-02-17 |
Submission filed in response to commitments made as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. PBRER #1 for the period 2021-11-14 to 2022-05-13. The information was reviewed and found acceptable. No further action was required. |
| Risk Management Plan update Control # 268894 | 2022-10-20 | Review completed 2023-02-07 |
The Canadian Addendum to the Risk Management Plan (RMP) succession #4 dated October 2022 and the draft protocol for a pregnancy study were filed as per the terms and conditions imposed on the authorization issued under the Food and Drug Regulations. The information was reviewed and found acceptable. No further action was required. |
| Health Professional Risk Communication | Not applicable | Posted 2023-01-17 |
Health Professional Risk Communication posted (Evusheld [tixagevimab and cilgavimab for injection] - Risk of Prophylaxis or Treatment Failure due to Antiviral Resistance to specific SARS-CoV-2 Subvariants), containing new safety information for health professionals. |
| SNDS # 270214 | 2022-11-30 | Issued NOC 2023-01-12 |
Submission filed as a Level II – Supplement (Safety) to update the PM with in vitro neutralization data for several Omicron subvariants. The submission was reviewed and considered acceptable. As a result of the SNDS, modifications were made to the Microbiology section of the PM. An NOC was issued. |
| NC # 270665 | 2022-12-15 | Issued NOL 2023-01-09 |
Submission filed as a Level II (90 day) Notifiable Change (Moderate Quality Changes) to transfer quality control testing of the drug product to a different site. The submission was reviewed and considered acceptable, and an NOL was issued. |
| NC # 270075 | 2022-11-25 | Issued NOL 2022-12-07 |
Submission filed as a Level II (90 day) Notifiable Change (Moderate Quality Changes) to transfer quality control testing of the drug substance to a different site. The submission was reviewed and considered acceptable, and an NOL was issued. |
| SNDS # 266528 | 2022-07-28 | Issued NOC 2022-11-09 |
Submission filed as a Level I – Supplement to change the dosing regimen for the pre-exposure prophylaxis of COVID-19 from a single 300 mg dose (150 mg tixagevimab and 150 mg cilgavimab) to a 600 mg dose (300 mg tixagevimab and 300 mg cilgavimab) every 6 months. The information was reviewed and considered acceptable. An NOC was issued. |
| Health Professional Risk Communication | Not applicable | Posted 2022-10-26 |
Health Professional Risk Communication posted (Evusheld [tixagevimab and cilgavimab for injection] - Risk of Prophylaxis or Treatment Failure due to Antiviral Resistance), containing information about product safety for health professionals. |
| SNDS # 265382 | 2022-06-22 | Issued 2022-10-18 |
Submission filed as a Level I – Supplement for a new indication. The indication authorized was: the treatment of mild to moderate COVID-19 in adult and adolescent patients (≥12 years of age weighing at least 40 kg). The submission was reviewed and considered acceptable, and an NOC was issued. A Regulatory Decision Summary was published. |
| NC # 265906 | 2022-07-08 | Issued NOL 2022-07-15 |
Submission filed as a Level II (90 day) Notifiable Change (Moderate Quality Changes) to extend the shelf life of lot CAAN from 18 to 24 months when stored at 2 oC to 8 oC. The submission was reviewed and considered acceptable, and an NOL was issued. |
| SNDS # 265693 | 2022-06-30 | Issued NOC 2022-07-28 |
Submission filed as a Level I – Supplement to add an alternate manufacturing site for the production of the cilgavimab and tixagevimab drug substances. There were no changes to the manufacturing process for the drug substances. The information was reviewed and considered acceptable. An NOC was issued. |
| Drug product (DIN 02526271) market notification | Not applicable | Date of first sale: 2022-04-19 |
The manufacturer notified Health Canada of the date of first sale pursuant to C.01.014.3 of the Food and Drug Regulations. |
| Health Product Risk Communication | Not applicable | Posted 2022-04-14 |
Health Professional Risk Communication posted (Distribution of Evusheld [tixagevimab and cilgavimab for injection] with English-Only Vial and Carton Labels), containing important information about labelling and supply for healthcare professionals. |
| NDS # 258295 | 2021-11-03 | Issued NOC (subject to terms and conditions) 2022-04-14 |
NOC issued for New Drug Submission. Terms and conditions were imposed on the authorization. |