Novartis hopeful for novel heart drug
Experts fear fatal infection risks
ZURICH, Aug 28, (RTRS): Novartis will seek regulatory approval this year for a new kind of anti-inflammatory heart drug, though some experts fear fatal infection risks and a high price may overshadow the medicine’s limited benefits.
Keenly awaited clinical trial results released on Sunday showed heartattack survivors on one of three doses of canakinumab were 15 percent less likely to suffer another major cardiac event than those on a placebo.
Novartis had said in June that the drug met its goal in the study but details were only unveiled at European Society of Cardiology meeting in Barcelona. One leading expert described the benefit as “modest”.
Patients getting canakinumab also suffered significantly more deaths from infections than those on placebo — but, on the positive side, they appeared to be at lower risk of cancer.
There was no significant difference in the rate of deaths from all causes between the placebo group and those on canakinumab.
“The modest absolute clinical benefit of canakinumab cannot justify its routine use in patients with previous myocardial infarction until we understand more about the efficacy and safety trade-offs and unless a price restructuring and formal cost-effectiveness evaluation supports it”, wrote Dr Robert Harrington, chair of the Stanford University School of Medicine, in an editorial in the New England Journal of Medicine.
Canakinumab had stirred considerable scientific interest because it appears to finally deliver proof that fighting inflammation offers a promising new way to counter heart disease in patients who already get cholesterollowering treatment.
Subsequently, some analysts boosted their revenue estimates for the Novartis medicine into the billions of dollars, while awaiting the data announced on Sunday.
Canakinumab is already approved as Ilaris for rare autoimmune conditions.
Vas Narasimhan, Novartis’s head of global drug development, said the drugmaker plans to go to regulators in the fourth quarter to seek approval for canakinumab to treat heart-attack victims with high levels of inflammation.
He downplayed critics who said the benefit was small, saying that one large subgroup in the so-called Cantos trial had shown a 27 percent reduction in cardiovascular risk.
Novartis also plans to underscore canakinumab’s potential cancer fighting properties with the European Medicines Agency and the US Food and Drug Administration.
That’s after an analysis of Cantos data found total cancer mortality among patients getting canakinumab was significantly lower than in those receiving the placebo.
Narasimhan, who said the company now plans to start separate cancer trials for canakinumab, said the drug could be particularly suitable for smokers with risks of both lung cancer and heart problems.
With the oncology findings promising but only preliminary, the company is planning additional studies in lung cancer starting next year, he said.