Canakinumab

ArticlesRefrigerated StorageLactation Safety InformationNew Medicines ·
16591711000001109

Articles

Refrigerated Storage

IlarisNovartis Pharmaceuticals

Novartis Pharmaceuticals
Ilaris
150mg powder for solution for injection (vial)

Contact Novartis Medical Information in all cases where a deviation from the recommended storage conditions has occurred.

Details of the temperature excursion and the product batch number will be requested.

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Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

14 May 2020
London Medicines Information Service

Lactation Safety Information

For inherited auto-inflammatory disorders

For inherited auto-inflammatory disorders
-
No published evidence of safety
Low levels anticipated in milk due to the drug’s properties. However, long half-life increases risk of accumulation in breastfed infants
Although large protein molecules may appear in colostrum, risk to preterm infants and neonates is considered to be small and unproven
17 September 2020

For acute gout

For acute gout
NSAIDs
No published evidence of safety
Low levels anticipated in milk due to the drug’s properties. However, long half-life increases risk of accumulation in breastfed infants
Although large protein molecules may appear in colostrum, risk to preterm infants and neonates is considered to be small and unproven
17 September 2020

New Medicines

IlarisSecondary prevention of cardiovascular events

Information

Ilaris
Licence extension / variation
Novartis
Novartis

Development and Regulatory status

Discontinued
Discontinued
Discontinued
Dec 19Novartis no longer lists this indication in its pipeline, they have advised that they will not be pursuing a marketing authorisation application from the EMA [17, 18].
Jan 19Novartis has no current plans to re-file for this indication or conduct further trials [16].
Dec 18CHMP indicates that following the company responses to the last round of questions, there were still unresolved issues. Based on their review of the data and responses, CHMP had the provisional opinion that the extension to the indications could not have been approved. In particular, it considered that the data were not robust enough to demonstrate clearly that the drug is effective for secondary prevention in all patients. The benefits were considered modest and insufficient to outweigh the increased risk of serious infection in patients receiving canakinumab: overall, therefore, the CHMP opinion was that the benefits did not outweigh the risks [15].
Dec 18Filing in EU withdrawn - the company is yet to provide any further details [14]
Oct 18Company received a complete response letter (CRL) from FDA regarding the supplemental Biologics License Application for cardiovascular risk reduction and they are evaluating the feedback provided. [13]
Jan 18Novartis reported that the company has filed an sBLA and MAA with the US FDA and the EMA, respectively, for the approval of canakinumab for the prevention of cardiovascular disorders [11].
Nov 17Novartis plans to file CANTOS data for regulatory approval in Q4 2017. Canakinumab is currently marketed in the US for orphan indications with a price per vial of >$16,000, but a lower price is predicted following launch for this new indication [10].
Oct 15Plans for filing in 2017 unchanged [5].
Jul 14Filings planned 2017 [4].
Jul 13Regulatory filings planned to start 2016 [3]
Aug 11Global PIII study started [1].

Category

Interleukin 1-beta inhibitor
The average incidence of MI for those aged between 30 & 69 years is about 600 per 100,000 for men, & 200 per 100,000 for women [2].
Secondary prevention of cardiovascular events
Subcutaneous

Further information

Yes
Suspended

Trial or other data

Nov 18An exploratory pre-specified analysis of the PIII CANTOS study (NCT01327846) suggests that canakinumab has a dose-dependent reduction in hospitalisation for HF (HHF) and composite of HHF/HF-related mortality, versus placebo in 10,061 patients with prior MI and elevations in CRP [13].
Mar 18Two new analyses of data from more the CANTOS study were presented at the 2018 American College of Cardiology meeting. Investigators found that canakinumab substantially reduced cardiovascular event rates in high-risk atherosclerotic patients with chronic kidney disease (CKD) or those with pre-diabetes/diagnosed type 2 diabetes. In chronic kidney disease patients, the drug reduced the risk of MACE by 18% over placebo. For patients with diabetes, the reduction was 10%, while those with prediabetes experienced a 14% risk reduction. The drug didn´t prevent prediabetes patients from progressing to diabetes. Results from diabetes patients have been published in the Journal of the American College of Cardiology [12].
Nov 17Novartis announced results of a pre-planned secondary analysis of results of an exploratory endpoint of the PIII CANTOS trial showing that a subgroup of post MI patients (about 55% of the trial subjects) who achieved hsCRP levels <2mg/L at three months after receiving the first dose of canakinumab had a 25% reduction in MACE vs. placebo (p<0.0001). These patients also had a significant reduction of 31% in the rate of CV death (p=0.0004) and all-cause death (p<0.0001). There was no significant reduction in these endpoints observed among those treated with canakinumab who achieved hsCRP levels 2mg/L or more, suggesting that on-treatment hsCRP testing may offer a way of indentifying the patients most likely to achieve the greatest benefits from canakinumab treatment. These results have been published in the Lancet [10].
Aug 17Data from the CANTOS study presented at the European Society of Cardiology (ESC) Congress. The study showed a significant 15% reduction of major adverse cardiovascular events (MACE) in people with a prior heart attack and inflammatory atherosclerosis who were treated with 150mg canakizumab in addition to standard of care (p=0.021). Results have been published in the NEJM. Secondary results indicate that canakinumab may reduce the risk of lung cancer. This was added as a secondary outcome as a lead researcher was aware that the pathway that canakinumab acts on is also important in cancer. The study results showed a significant and dose-related reduction in lung cancer risk in patients receiving canakinumab vs placebo: as a result, Novartis plans to initiate a PIII trial specifically examining the drug´s potential in this indication [8,9].
Jun 17Novartis announces topline results for CANTOS - when added to standard care, canakinumab met its primary outcome, reducing risk of major adverse cardiovascular events (MACE). Full results will be presented and published during 2017 [7].
Dec 16The PIII CANTOS study (NCT01776424) is ongoing, but no longer recruiting participants, with an estimated final data collection date for the primary outcome measure of Feb 2017 [6].
Apr 11NCT01327846 is a randomized, double-blind, placebo-controlled, event driven PIII trial of quarterly subcutaneous canakinumab in the prevention of recurrent cardiovascular events among 7302 stable post-myocardial infarction patients with elevated hsCRP. The primary outcome is time to first occurrence of a major adverse cardiovascular event (composite of CV death, non-fatal MI and stroke). The study started in Apr 11 and is due to complete Dec 16 [1].

Evidence based evaluations

Ilaris Metastatic non-small cell lung cancer (NSCLC) - first-line maintenance therapy

Information

Ilaris
Licence extension / variation
Novartis
Novartis

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

Interleukin 1-beta antagonist
The incidence rate of lung cancer in 2006 was 72.2 per 100,000 in men and 50.8 per 100,000 in women. Lung cancer belongs to the three most common cancers in men (14.8 % of all cancers) and women (10.9% of all cancers).
Metastatic non-small cell lung cancer (NSCLC) - first-line maintenance therapy
Subcutaneous injection

Ilaris Metastatic non-small cell lung cancer (NSCLC) - second- or third-line

Information

Ilaris
Licence extension / variation
Novartis
Novartis

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

Interleukin 1-beta antagonist
The incidence rate of lung cancer in 2006 was 72.2 per 100,000 in men and 50.8 per 100,000 in women. Lung cancer belongs to the three most common cancers in men (14.8 % of all cancers) and women (10.9% of all cancers).
Metastatic non-small cell lung cancer (NSCLC) - second- or third-line
Subcutaneous injection

IlarisNon-small cell lung cancer (NSCLC), II-IIIA and the subset of IIIB (T>5cm N2 disease) completely resected - adjuvant therapy

Information

Ilaris
Licence extension / variation
Novartis
Novartis

Development and Regulatory status

None
None
Phase III Clinical Trials

Category

Interleukin 1-beta antagonist
The incidence rate of lung cancer in 2006 was 72.2 per 100,000 in men and 50.8 per 100,000 in women. Lung cancer belongs to the three most common cancers in men (14.8 % of all cancers) and women (10.9% of all cancers)
Non-small cell lung cancer (NSCLC), II-IIIA and the subset of IIIB (T>5cm N2 disease) completely resected - adjuvant therapy
Subcutaneous injection