- A heart medication that Novartis hoped could eventually bring in at least $1 billion a year has failed a late-stage study, the company announced Wednesday.
- The Phase 3 trial tested RLX030, also known as serelaxin, in patients with acute heart failure (AHF). About 1-2% of the population has AHF, though it is more common in older patients, according to the European Society of Cardiology. The condition has a high mortality rate, with some estimates asserting that nearly one in five hospitalizations result in death.
- Serelaxin failed to extend the time before patients' heart failure worsened or before they died from cardiovascular complications when added to standard therapy. Three other studies testing the drug remain underway, but Novartis is "evaluating how best to responsibly close these studies early," a spokesman said via email.
While no drugmaker wants a Phase 3 failure, it's a even tougher blow when the drug targets a particularly lucrative market. Novartis had predicted in the past that serelaxin could reach blockbuster status.
The Swiss giant has one of the more robust late-stage pipelines in the industry, however, which helps soften this setback. And recently approved Kisqali (ribociclib), a breast cancer treatment, and the two year-old Cosentyx (secukinumab) should provide revenue growth in the face of patent expiries.
In the cardio-metabolic space, two other cardiovascular drugs have been tagged by the company as potential growth drivers.
Entresto (sacubitril/valsartan), already approved to treat chronic heart failure and reduced ejection fraction, is under investigation as a medication for patients who have heart failure after a myocardial infarction. Last year, the drug earned $170 million — a slower launch than Novartis had hoped for but one the company hopes to quickly build on.
Ilaris (canakinumab), meanwhile, is in Phase 3 testing for secondary prevention of cardiovascular events. The drug has actually been a part of Novartis' immunology and dermatology portfolio, and received the green light from the Food and Drug Administration for several indications, including rare pediatric fever syndromes and some autoimmune diseases. The product had revenues of $283 million in 2016, up 20% from the year prior.
Serelaxin's failure likely will put more pressure on Entresto to deliver on expectations and help grow the company's cardio-metabolic offerings moving forward. Despite the sluggish launch, Novartis has upped its investment in marketing Entresto and launched new studies to expand evidence of the drug's benefit.
"We are disappointed this study did not confirm the efficacy of RLX030 in acute heart failure, especially given the urgent need for effective new treatments for this condition," Novartis' Chief Medical Officer Vas Narasimhan said in a March 22 statement. "We will continue to further analyze the data to better understand and learn from these results as well as evaluate next steps for the overall program."