Regulatory Decision Summary for Kineret

 

Decision issued

No decision was issued by Health Canada. The company chose to cancel its submission before a final decision was issued.

Date of cancellation

October 29, 2021

What was the purpose of this submission?

The purpose of this submission is to extend the authorization of Kineret (anakinra) to include the treatment of Still’s disease in pediatric patients (also known as systemic juvenile idiopathic arthritis [SJIA]) and in adult patients (also known as adult-onset Still’s disease [AOSD]).

What did the company submit to support its submission?

This submission was filed under the Health Canada Guidance Document: Drug Submission Relying on Third-party Data (SRTD). Limited pharmacology data from the use of Kineret in Still’s disease were provided from two sponsor-conducted clinical trials and multiple publications identified by a systematic literature review. To support a claim of efficacy for anakinra in the treatment of patients with Still’s disease (SJIA and AOSD) the following materials were provided to Health Canada:

• A systematic literature review of anakinra in pediatric and adult patients with Still’s disease, which identified 25 studies;
• Case studies with < 5 patients reporting the efficacy of anakinra in Still’s disease that were not included in the SLR;
• A published meta-analysis based on 9 published studies on the efficacy and safety of anakinra in patients with SJIA (Meta-analysis SJIA);
• A published meta-analysis based on 8 published studies on the efficacy and safety of anakinra in patients with AOSD (Hong et al. 2014);
• A company-sponsored prospective, multicentre randomized JIA trial with a subgroup of 15 patients with SJIA starting with a 12-week open-label run-in phase with anakinra treatment to select responders to the subsequent 16-week randomized withdrawal, double-blind, placebo-controlled treatment phase, ending with a 12-month open-label extension phase, also published by (Ilowite et al. 2009) and identified in the SLR. Due to difficulties in patient recruitment, the primary objective was amended to assess safety; and
• A company-sponsored 12-week randomized, double-blind, placebo-controlled, multicentre trial in 12 newly diagnosed patients with Still’s disease (6 anakinra-treated patients and 6 placebo-treated patients evaluable for efficacy). The study was prematurely terminated due to difficulties in patient enrollment.

What was the status of the submission when it was cancelled? What was Health Canadas assessment of the submission at the time of cancellation?

On 04 March 2021, Health Canada issued a Notice of Deficiency for the submission.

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.

There are two alternative biologics authorized in Canada for the treatment of patients with systemic juvenile idiopathic arthritis or Still’s Disease.

Additional information

*Proposed Brand Name:

Kineret