Regulatory Decision Summary for Nucala
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:
Summary of Cancellation for NUCALA (Control number 212242)
Medicinal ingredient(s):
Therapeutic area:
Type of submission:
Control number:
Overview
Decision issued
GlaxoSmithKline Inc. cancelled the submission before a final decision was issued by Health Canada.
Date of cancellation
2018-10-18
What was the purpose of this submission?
GlaxoSmithKline Inc. filed a SNDS to propose Nucala (mepolizumab for injection) Lyophilized Powder for Subcutaneous Injection as an add-on maintenance treatment for adult patients with chronic obstructive pulmonary disease (COPD).
What did the company submit to support its submission?
GlaxoSmithKline Inc. submitted clinical and labelling components.
What was the status of the submission when it was cancelled? What was Health Canadas assessment of the submission at the time of cancellation?
The submission review was ongoing at the time of cancellation. Health Canadas assessment of the submission at the time of cancellation had identified issues with the evidence provided to support the proposed new indication. These issues were not resolved at the time the sponsor cancelled the submission.
What consequences does the cancellation have for patients accessing the drug under the Special Access Programme (SAP), or via clinical trials?
Nucala is currently authorized for sale in Canada for the treatment of subjects with severe eosinophilic asthma or eosinophilic granulomatosis with polyangiitis. No consequences to patients accessing Nucala under the SAP or via clinical trials is expected as a result of the cancellation of the submission.
Additional information
Proposed Brand Name
Nucala
Date filed
2017/12/18