Ilaris® receives Health Canada approval as first of its kind treatment for rare, inflammatory disorder, adult-onset Still's disease

  • The approval of Ilaris (canakinumab) in the treatment of adult-onset Still's disease (AOSD) brings hope for Canadians living with this rare, debilitating, and sometimes life-threatening inflammatory disorder.
  • Ilaris, an interleukin-1 beta inhibitor, provides a new mode of treatment for this disease which previously had limited options.1,2

DORVAL, QC, April 29, 2021 /CNW Telbec/ - Novartis Pharmaceuticals Canada Inc. is pleased to announce that Health Canada has approved Ilaris® (canakinumab) for the treatment of active Still's disease, including adult-onset Still's disease (AOSD)1. AOSD is a rare form of inflammatory arthritis that can be a complex disease with variable presentation and potentially life-threatening complications2.

This new indication follows the existing approval of Ilaris for Systemic Juvenile Idiopathic Arthritis (SJIA)1, now allowing patients over the age of 16 to be treated. Characteristics of AOSD have considerable overlap with SJIA, which includes fever, arthritis, rash and elevated markers for inflammation, suggesting these as similar conditions under the same disease continuum but with different ages of onset3. AOSD is complex, multigenic, disruptive, and difficult to diagnose4. The disease can vary from an indolent chronic condition to a severe and highly symptomatic one from patient to patient2,4.

"The availability of Ilaris for the treatment of adult-onset Still's disease represents a significant advancement for Canadians currently suffering from this potentially life-threatening autoinflammatory condition, and also for the expansion of research in this field," said Dr. Derek Haaland, rheumatologist, clinical immunologist and allergist in Barrie, Ontario. "This development also brings with it much-needed awareness of AOSD and other related autoinflammatory disorders that are rare and too often don't receive the attention they deserve."

New treatments have been slow to develop for AOSD, in part because its rarity and complexity make it difficult for the scientific community to study4. While the clinical manifestations of AOSD are similar to other autoinflammatory diseases in some ways, including the characteristic of interleukin involvement, it is differentiated by the length and severity of flares, the occurrence of bone and cartilage destruction, and the apparent lack of genetic origin4. As such, the availability of a therapy for AOSD that inhibits interleukin-1 beta is significant.

"With rare autoinflammatory diseases like AOSD, we are especially eager to provide new treatment options for patients who too often have limited options," said Andrea Marazzi, Country Head, Novartis Pharmaceuticals Canada. "We are proud to announce this latest approval for Ilaris and are hopeful that it will open the door to reimagining care for adult Canadian patients."

Ilaris is a genetically engineered high-affinity human anti-human-interleukin-1 beta (IL-1β) monoclonal antibody, administered by subcutaneous injection every four weeks in the treatment of AOSD1. As a targeted biological therapy, Ilaris is an entirely new mode of treatment for this disease, which has historically been managed with corticosteroids and nonsteroidal anti-inflammatory drugs1,2.

AOSD is estimated to affect less than one per 100,000 people3. First described in 1971, the disorder presents with high spiking fevers, skin rash, sore throat, abnormal liver function, and joint symptoms4.

In addition to AOSD and SJIA, Ilaris is also approved for a number of autoinflammatory Periodic Fever Syndromes, including Cryopyric-Associated Periodic Syndrome (CAPS) in adults and children1.

About Novartis Pharmaceuticals Canada
Novartis Pharmaceuticals Canada Inc., a leader in the healthcare field, is committed to the discovery, development and marketing of innovative products to improve the well-being of all Canadians. In 2020, the company invested $45 million in research and development in Canada. Located in Dorval, Quebec, Novartis Pharmaceuticals Canada Inc. employs approximately 1,000 people in Canada and is an affiliate of Novartis AG, which provides innovative healthcare solutions that address the evolving needs of patients and societies. For further information, please consult www.novartis.ca.

About Novartis
Novartis is reimagining medicine to improve and extend people's lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world's top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 110,000 people of more than 140 nationalities work at Novartis around the world. Find out more at https://www.novartis.com.

References

1.

Novartis Pharmaceuticals Canada, Inc. ILARIS Product Monograph. February 22, 2021

2.

Y Jamilloux, M Gerfaud-Valentin, T Henry, P Sève. Treatment of adult-onset Still's disease: a review. Therapeutics and Clinical Risk Management 11, pp 33-43. Available at : https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4278737/

3.

Efthimiou P., Yadlapati S. (2019) Adult-Onset Still's Disease. In: Efthimiou P. (eds) Auto-Inflammatory Syndromes. Springer, Cham. Available at: https://doi.org/10.1007/978-3-319-96929-9_19

4.

M Gerfaud-Valentin, Y Jamilloux, J Iwaz, P Sève. Adult Onset Still's Disease. Autoimmunity Reviews 13, pp 708-722. Available at: https://www.sciencedirect.com/science/article/pii/S1568997214000986

Ilaris is a registered trademark.

SOURCE Novartis Pharmaceuticals Canada Inc.

Back to news