Regulatory Decision Summary for Plivensia
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 : sirukumab - PLIVENSIA
Medicinal ingredient(s):
Therapeutic area:
Type of submission:
Control number:
Overview
Decision issued
No decision was issued by Health Canada. The company cancelled the submission before a final decision was issued due to an internal business decision.
Date of cancellation
October 19, 2017
What was the purpose of this submission?
The proposed indication for Plivensia (sirukumab) was for the treatment of moderately to severely active rheumatoid arthritis (RA), including the reduction of signs and symptoms and inhibition of progression of structural damage, in adult patients who have had an inadequate response or are intolerant to one or more conventional nonbiologic or biologic disease modifying antirheumatic drugs (DMARDs).
What did the company submit to supports its submission?
The sponsor submitted pre-clinical, clinical, quality 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?
At the time of the cancellation, the clinical, quality and labelling reviews were pending.
What consequences does the cancellation have for patients accessing the drug under the Special Access Programme (SAP), or via clinical trials?
According to the Canadian Rheumatology Association guidelines, there are several traditional and biologic disease-modifying antirheumatic drugs (DMARD). Therefore, the cancellation of Plivensia (sirukumab) is unlikely to have an impact on either the SAP or patients in clinical trials.
Additional information
*Proposed Brand Name:
Plivensia