Novartis has filed suit against AstraZeneca’s rare disease unit, claiming that certain marketing materials for Alexion’s Ultomiris create an inaccurate impression of Novartis’ rival drug Fabhalta.
Both Ultomiris and Fabhalta are approved to treat paroxysmal nocturnal hemoglobinuria (PNH), among other autoimmune diseases on the meds’ labels. In an Oct. 17 filing in Delaware federal court, Novartis took issue, in part, with a page on Ultomiris’ U.S. healthcare professional-facing website offering information about the drug’s effects.
Under the bolded heading “Block the cause,” the webpage touts Ultomiris for its ability to induce complete inhibition of the terminal complement, activation of which can lead to potentially life-threatening PNH complications. Though the site doesn’t mention Fabhalta, a proximal complement inhibitor, by name, it does say that “proximal complement inhibition may not lead to complete terminal complement inhibition”—an “implied superiority claim,” per Novartis, that “lacks any evidentiary support.”
Novartis went on in the complaint to argue that “Alexion has gone to great lengths to spread its false messaging” beyond the website, including in verbal discussions with HCPs, sales calls and “Alexion-sponsored symposia,” where it has allegedly asserted that, in contrast to terminal complement inhibitors like Ultomiris, proximal complement inhibitors like Fabhalta don’t fully block terminal complement activity and can lead to an increased risk of infection.
The marketing materials and activities cited in the dispute date back at least to March 2025, per Novartis.
In sum, Novartis accused Alexion of launching “a false and misleading marketing campaign that is unsupported by scientific evidence and wrongly suggests that its product, ULTOMIRIS (ravulizumab), is superior in efficacy and safety to Novartis’ FABHALTA (iptacopan) for treating paroxysmal nocturnal hemoglobinuria.”
According to the Swiss pharma, clinical data suggest that Fabhalta is “at least as effective” as Ultomiris in treating PNH and controlling potential complications like intravascular hemolysis and thrombosis.
“Alexion’s deceptive messaging misleads healthcare professionals, distorts prescribing decisions, and harms both Novartis and the patients who rely on accurate, evidence-based information,” Novartis wrote in the filing.
Alexion declined to comment on ongoing litigation.
Novartis said in the complaint that it reached out to Alexion in March 2025, “warning of the significant public health concerns posed” by the “Block the Cause” campaign and requesting that Alexion immediately cease the claims. According to Novartis, Alexion responded a month later with a letter that “doubled down” on its claims of the superiority of terminal complement inhibitors in treating PNH.
In the filing, Novartis requested a jury trial and an injunction forcing Alexion to cease its “unfair competitive tactics,” which, it claims, “are causing immediate and irreparable competitive and commercial injury to Novartis and to its goodwill and reputation.”
Novartis also said it is entitled to damages—of an amount to be determined by the court—based, in part, on sales that may have been diverted from Fabhalta to Ultomiris by Alexion’s marketing materials.