Summary of Cancellation for XEOMIN

Review decision

The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.


Product type:

Drug

Contact:

Medicinal ingredient(s):

IncobotulinumtoxinA

Therapeutic area:

Muscle relaxant, peripherally acting agent

Type of submission:

Supplement to a New Drug Submission (SNDS)

Control number:

268590

Decision issued:

No decision was issued by Health Canada. The company cancelled its submission before a final decision was issued.

Date of cancellation:

2023-10-06

What was the purpose of this submission?

The purpose of this Supplement to a New Drug Submission (SNDS) was to seek market authorization for Xeomin (incobotulinumtoxinA) in the treatment of spasticity (SP) of the lower (LL) and upper limb (UL) in pediatric patients (age 2-17 years).

What did the company submit to support its submission?

The company submitted data from 4 clinical studies. Two controlled, double-blind, randomized clinical trials were determined as pivotal.

What was the status of the submission when it was cancelled? What was Health Canada’s assessment of the submission at the time of cancellation?

At the time of cancellation, Health Canada had completed the assessment of the data provided to support the proposed indication. The clinical efficacy data that were provided did not support the clinical benefit of Xeomin for the proposed indication. The company chose to cancel their submission without prejudice to refiling.

What consequences does the cancellation have for patients accessing the drug under the Special Access Programme (SAP), or via clinical trials?

There is no expected impact for patients using SAP or in clinical trials.

For more information about the Special Access Programme refer to the programme’s web site: http://www.healthcanada.gc.ca/sap or http://www.santecanada.gc.ca/pas

Brand Name:

Xeomin

Manufacturer:

Merz Pharmaceuticals GmbH / Merz Pharma Canada Ltd.

Drug Identification Numbers issued:

N/A

Date filed:

2022-10-07

Date modified: