Novartis has posted surprise phase III data that could transform the fortunes of its anti-inflammatory drug Ilaris, making it an option to reduce cardiovascular complications in people who have suffered a heart attack.
The CANTOS study showed that the active ingredient in Ilaris – canakinumab or ACZ885 – reduced major adverse cardiovascular events (MACE: cardiovascular death, non-fatal myocardial infarction and non-fatal stroke) in patients with a prior heart attack and inflammatory atherosclerosis when added to standard therapy.
Ilaris is an interleukin-1 beta inhibitor and has been on sale since 2009, gradually picking up approvals for a range of inflammatory diseases including juvenile-onset rheumatoid arthritis, gouty arthritis and most recently periodic fever syndrome.
The drug has been a slow burner so far, bringing in $283m in sales last year, but could see its sales rocket if it claims approval for at-risk cardiovascular patients, with some analysts suggesting it could develop into a $2bn-a-year product if Novartis can get approval for the new use.
Novartis has previously suggested that some 4m people in the world’s largest markets could benefit from the drug, and analysts at Bernstein think that could translate into ‘multi-billion dollar’ sales.
Shares in the company rose more than 3% as investors digested the news, excited by the prospect of adding another big cardiovascular product to sit alongside the company’s new chronic heart failure therapy Entresto (sacubitril/valsartan) – also predicted to become a blockbuster but currently growing slowly thanks largely to payer resistance in the US.
There is still some way to go before approval – including presenting the data to cardiologists (most likely at the European Society of Cardiology Congress in August) – and discussing with regulators what may be required for a marketing application.
Even if approved, Novartis’ experience with Entresto reveals how getting uptake of a pricey new drug can be challenging. Ilaris has a list price of around $200,000 a year, but for now it is unclear what pricing structure might be used for a cardiovascular indication, and payer pushback may be less of a factor if the benefit on MACE is sizeable.
Novartis’ chief medical officer Vas Narasimhan is hopeful. “Despite current treatment, about 25% of heart attack survivors will have another cardiovascular event within five years,” he points out.
“ACZ885 is the first and only investigational agent which has shown that selectively targeting inflammation reduces cardiovascular risk.”