Dow component Johnson & Johnson (JNJ) and Bayer (BAYRY) will have an uphill battle in persuading doctors to add Xarelto to aspirin therapy for heart-disease patients, analysts said Monday after a trial showed some complications.
XAutoplay: On | OffXarelto, a blood thinner, was tested alone and in combination with aspirin to cut down the risk of cardiac events in patients with some heart diseases. The combo reduced the risk of cardiovascular death, stroke or heart attack by 24% vs. aspirin alone.
But it was also tied to more bleeding events. These events occurred in 3.1% of patients treated with the combination vs. 1.9% of patients treated with aspirin alone. Most of the bleeding occurred in the gastrointestinal tract, Johnson said in a news release.
“Encouragingly, the trial found no difference in the rates of fatal bleeds, intracranial bleeding or symptomatic bleeding into a critical organ,” RBC analyst Glenn Novarro wrote in a note to clients.
The results appear sufficient for the Food and Drug Administration to approve Xarelto in combination with aspirin in this setting, Novarro said. Doctors commonly use aspirin-only therapy to help cut down on the risk of cardiac events in heart-disease patients.
Novarro notes the benefit/risk profile could have a “potential impact on peak sales for Xarelto.” Credit Suisse analyst Vamil Divan, though, is more bullish. He notes the combo cut the risk of stroke and cardiovascular death by 42% and 22%, respectively.
None of the bleeding in the trial proved fatal or occurred in the brain, he wrote in a note to clients. These results could “drive a re-acceleration of growth for Xarelto as it expands the potential treatment population for the product by more than 50%,” he said.
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Fellow drugmaker Novartis (NVS) will be more challenged with its drug known as Ilaris, Leerink analyst Seamus Fernandez said in a note to clients. In a Phase 3 trial, Ilaris cut down on the risk of major cardiac events in heart-attack survivors by 15% vs. a placebo.
“We see these results, together with a lack of a significant benefit in cardiovascular mortality, as underwhelming and unlikely to result in a reasonable commercial opportunity for the drug in this overall population,” he wrote.
Overall, Ilaris showed a 24% relative reduction in the risk of heart attack and a 10% cut in the risk of cardiovascular death. In a subgroup of patients who hit a specific level of inflammation after the first dose, Ilaris resulted in a 27% cut in the risk of major cardiovascular events.
Ilaris could have some legs in this group if Novartis can define the subgroup with regulators and negotiate with health insurers, Fernandez said.
“Despite this, we believe the drug could still struggle to gain meaningful uptake based on the recent experience with anti-PCSK9 antibodies, and note that the current patent life of the drug extends to only 2024,” he wrote.
PCSK9 inhibitors are cholesterol-reducing drugs from the likes of Amgen (AMGN) and Regeneron Pharmaceuticals (REGN)/Sanofi (SNY). Cutting “bad” LDL cholesterol has been shown to have a benefit on the cardiovascular side as well, but PCSK9 inhibitors have struggled to gain uptake.