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Novartis nabs new FDA approvals for Ilaris and Cosentyx

Drug gets first-ever green light in rare disorder Still’s disease

Novartis HQ

Novartis started the week with a pair of new approvals from the FDA, including a first-ever green light in rare disorder Still’s disease for its IL-1β inhibitor Ilaris and new indication for IL-17 blockbuster Cosentyx.

Ilaris (canakinumab) is already approved in the US as a treatment for systemic juvenile idiopathic arthritis (SJIA) and periodic fever syndromes (PFS), and is also being put through its paces as a possible treatment for the runaway inflammation that afflicts some people with COVID-19.

The new approval from the FDA covers adult-onset Still's disease or AOSD, which according to the FDA has a number of similarities with SJIA and may be on the same “disease continuum”.

AOSD is a rare and severe autoinflammatory disease of unknown cause that, like SJIA, is characterised by fever, arthritis and rash, and occurs at a prevalence of less than one case per 100,000 people in the US, according to estimates.

It can lead to hepatitis and liver failure, and is typically treated with high-dose steroids, as non-steroidal anti-inflammatory drugs (NSAIDs) – which are sometimes used to help manage SJIA – are ineffective in most AOSD patients.

Ilaris – given as a once-monthly injection to suppress inflammation – was approved mainly on the back of extrapolating data in SJIA to the AOSD setting, as well as a supportive placebo-controlled trial in 36 AOSD patients.

SJIA is more common, occurring in somewhere between 5 and 15 people per 100,000. That’s also rare, but hasn’t stopped sales of the drug growing steadily since launch in 2013 for SJIA to $671m in 2019, helped by the addition of PFS to the label in 2016.

It’s still a long way short of Novartis’ earlier hopes of $5bn in peak sales for the drug, however, which centred on use of the drug to reduce the risk of major cardiovascular events in patients with prior heart attack and atherosclerosis.

That hypothesis hit the wall when the results of the CANTOS trial failed to convince the FDA that Ilaris could be approved in that indication, with the agency rejecting Novartis’ marketing application in 2018.

The drug is, however, still in the late-stage CANOPY trials programme for non-small cell lung cancer (NSCLC), which could give the drug some more upside growth, although it’s only a few years away from patent expiries that start in 2024.

Cosentyx in spondyloarthritis

The new FDA approval for Cosentyx (secukinumab) was for active non-radiographic axial spondyloarthritis (nr-axSpA), a disease characterised by inflammatory arthritis of the spine associated with chronic inflammatory back pain.

Cosentyx was the first IL-17 inhibitor to be approved for marketing in 2015 – getting the go-ahead for plaque psoriasis – and has since also been cleared for psoriatic arthritis and ankylosing spondylitis, driving sales to more than $3.5bn last year.

It wasn’t the first drug in the class for nr-axSpA, however, as Eli Lilly’s rival Taltz (ixekizumab) claimed a short-lived lead in that indication just a few days ago.

Lilly’s drug has been trying to close the gap on Cosentyx since making its debut for psoriasis in 2016, making almost $1.4bn last year after seeing its label extended to include psoriatic arthritis, genital psoriasis and ankylosing spondylitis.

Article by
Phil Taylor

18th June 2020

From: Research, Regulatory



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