- Novartis unveiled landmark clinical results on Thursday illustrating that one of its drugs aimed at reducing inflammation can also curb the risk of heart disease.
- The Swiss pharma's drug Ilaris (canakinumab), combined with standard of care treatment, was able to lower the risk of major adverse cardiovascular events (MACE) for patients with a history of heart attacks or hardened, inflamed arteries significantly better than placebo.
- Further results from the Phase 3 CANTOS trial investigating Ilaris as a potential heart health drug will come at later medical conference, according to a June 22 statement. The study enrolled more than 10,000 participants and lasted for about six years.
Large cardiovascular outcomes studies have become a useful, albeit risky, tool for drugmakers looking to show a product has a wide breadth of health benefits or lock down their place in increasingly crowded market. Amgen conducted one for its cholesterol medication Repatha (evolocumab) in the FOURIER trial, which enrolled more than 27,000 patients. So did Johnson & Johnson, Eli Lilly and Boehringer Ingelheim for their respective diabetes treatments, Invokana (canagliflozin) and Jardiance (empagliflozin).
Should such studies have positive data, as was the case for Jardiance, they can lead to lucrative label expansions. But they also cost millions of dollars and require years of research investment, meaning pharmaceutical companies have a lot to lose if their drugs flop, or even just demonstrate mixed results.
Fortunately for Novartis, Ilaris appears to be in the former group, though markets will have to wait for a more detailed readout to shed light on the magnitude of the drug's cardiovascular benefit. In CANTOS, the primary endpoint of MACE was a composite of cardiovascular death, non-fatal myocardial infarction and non-fatal stroke.
Most notable, however, is that the drug improves heart health specifically by addressing inflammation, rather than by other mechanisms like lowering cholesterol, as is the case with PCSK9 treatments.
Ilaris "is the first and only investigational agent which has shown that selectively targeting inflammation reduces cardiovascular risk," Novartis' Chief Medical Officer Vas Narasimhan said in the June 22 statement. "Our priority now is to thoroughly analyze these important data and discuss them with regulatory agencies."
With positive topline data in hand, Novartis will surely be focusing more on the potential pricing of its drug. Ilaris is already on the market as a treatment for active systemic juvenile idiopathic arthritis and a handful of rare conditions, including cryopyrin-associated periodic syndrome (CAPS). It also carries a somewhat steep price tag of $16,055 per vial in the U.S., and patients often need multiple vials each year. According to a Novartis spokesperson, CAPS patients require six dosings annually, amounting to roughly $96,000 in total costs.
Ilaris is already a profitable drug. In 2016, net sales of Ilaris reached $283 million, a 20% year-over-year increase. But if Novartis can find a price point that resonates with physicians, payers and pharmacy benefit managers, the returns could be vast. Nearly 800,000 people in the U.S. suffer from a heart attack each year, according to the American Heart Association, meaning there is a huge patient population to tap into.
Earlier this year, Novartis said Ilaris has the potential to reach blockbuster status, along with at least a dozen other drugs from its pipeline.