Pharmaprojects R&D Pipeline News Feed
First approval for Ilaris
19 Jun 2009
Novartis has received its first market approval of Ilaris (canakinumab) in the US. Ilaris is a human monoclonal antibody directed against interleukin-1beta (IL-1B), indicated for the treatment of adults and children aged 4 years and over with cryopyrin-associated periodic syndrome (CAPS). Launch onto the US market for is anticipated for the 1st quarter of 2010. Novartis has also filed for approval in the EU, including in Switzerland.
CAPS includes a group of 3 clinically overlapping syndromes (familial cold auto-inflammatory syndrome, Muckle-Wells syndrome and neonatal-onset multisystem inflammatory disease), all of which are rare inherited auto-inflammatory conditions. Signs and symptoms include recurrent rash, fever/chills, joint pain, fatigue, and eye pain/redness. More severe forms can include additional symptoms such as deafness, systemic amyloidosis, significant central nervous system disabilities and substantial joint and bone deformities. The underlying cause of these syndromes is mutations in a single gene: NLRP-3 (also known as CIAS1), which encodes the protein cryopyrin. Mutations in cryopyrin lead to overproduction of IL-1, amongst other proinflammatory cytokines, which induces the sustained inflammatory symptoms observed clinically.
Ilaris joins rilonacept (Arcalyst) in the small armoury of drugs currently available for the treatment of CAPS. Arcalyst is a human cytokine Trap protein that blocks the activity of IL-1; it was developed by Regeneron and has been available in the US since 2008. Unlike Ilaris it acts on both IL-1alpha and beta subtypes, however, it is only approved for use in adults and children aged 12 years and over. Additionally, while Arcalyst must be administered on a once-weekly basis, Ilaris need only be dosed once every 8 weeks. Neither drug is yet approved for use in treating neonatal-onset multisystem inflammatory disease, so currently both are restricted for use in the two other CAPS disorders.
Having secured this crucial first approval, Novartis is planning to follow up with further filings for refractory gout, systemic juvenile idiopathic arthritis and Type II diabetes. These submissions are expected to begin after the first launch of Ilaris in 2010. To support these filings, Novartis is conducting a range of clinical trials in these conditions, as well as others such as COPD, to further broaden the range of patient groups which could benefit from Ilaris. It was previously in studies for rheumatoid arthritis and macular degeneration; however, Novartis announced it has no plans for further development in these indications.
