Novartis’s Detailed Pelacarsen Data Leave Little Hope For Other Lp(a)-Lowering Drugs

Novartis presented long-term data from the NEPTUNUS extension study of ianalumab for Sjögren’s disease at ACR 2026. Continuous treatment showed sustained improvements in disease activity and salivary flow, with no new safety issues. Patients switching from placebo to ianalumab also saw benefits. The FDA decision is expected this year.

Novo Nordisk's ziltivekimab and Novartis' pelacarsen failed to reduce cardiovascular events in trials, despite lowering inflammation and Lp(a) levels. Novo Nordisk will discontinue ziltivekimab development and recorded a DKK 4.6B impairment. Novartis is also halting pelacarsen's development. Both companies are exploring other trials or drugs.

Novartis' pelacarsen and Novo Nordisk's ziltivekimab failed to reduce cardiovascular events despite targeting Lp(a) and inflammation. Novartis' drug, tested on 8,300 patients, showed no benefit in preventing heart attacks or strokes. Novo Nordisk's trial on 6,300 patients also showed no reduction in major cardiovascular events. Both companies presented findings at the American Heart Association meeting.

Novartis' pelacarsen reduced lipoprotein(a) by 78% in a 7-year trial but failed to prevent heart attacks, strokes, or cardiovascular deaths in 8,323 adults with existing heart disease. The study, presented at the American Heart Association's Scientific Sessions, showed no significant differences in outcomes between the treatment and placebo groups. Serious adverse events were slightly higher in the pelacarsen group, with 19 cases of anaphylaxis reported.

Novartis and Novo Nordisk's late-stage heart drug trials failed to show benefits, according to results presented at the American Heart Association meeting. Both drugs, pelacarsen and an anti-inflammatory targeting IL-6, showed no reduction in heart attacks or strokes. The failures highlight the risks of over-relying on AI and new technologies in drug development, costing billions. Experts caution against hype surrounding AI's potential to cure diseases quickly.

Novartis confirmed that 9 tumors were reported in patients treated with its Zolgensma SMA gene therapy. Two cases showed evidence of vector integration into DNA, while the other seven were not causally linked. Over 6,000 patients have been treated with the therapy. Patient advocates raised concerns on social media, highlighting the importance of transparent communication. Regulators are assessing the evidence, according to SMA Europe.