Pregnant women with paroxysmal nocturnal hemoglobinuria (PNH) who receive Soliris (eculizumab) have higher chances of their babies surviving compared with those who don’t, with fewer miscarriages before 24 weeks, a meta-analysis study has found. Biosimilars of Soliris are also available. “Eculizumab appears to be safe and benefits pregnant women with…
Up to 1 in 4 people with paroxysmal nocturnal hemoglobinuria (PNH) who are treated with Ultomiris (ravulizumab-cwvz) or Soliris (eculizumab) experience clinically significant extravascular hemolysis — the destruction of red blood cells — but this isn’t typically associated with severe fatigue, a new global study reported. Soliris…
Treatment with Fabhalta (iptacopan) can ease fatigue and improve quality of life for people with paroxysmal nocturnal hemoglobinuria (PNH), according to data from two Phase 3 clinical trials. “These results … indicate that [Fabhalta] results in clinically meaningful disease control and meaningful improvements in the fatigue and [health-related…
Fabhalta (iptacopan) is now available in Canada, according to its developer Novartis, which noted that it’s the first — and so far, the only — approved oral treatment that can be used on its own for adults with paroxysmal nocturnal hemoglobinuria (PNH) who have hemolytic anemia, or…
Epysqli (eculizumab-aagh), a Soliris (eculizumab) biosimilar, is now available in the U.S. to reduce red blood cell destruction (hemolysis) in people with paroxysmal nocturnal hemoglobinuria (PNH). A biosimilar contains an active ingredient that’s highly similar to an approved biological medicine, or reference product, with no clinically meaningful differences…
Close monitoring and Empaveli (pegcetacoplan) dose adjustments before and after surgery effectively prevented episodes of breakthrough hemolysis,in a 67-year-old man with paroxysmal nocturnal hemoglobinuria (PNH), according to a case report in Spain. Hemolysis is a hallmark symptom of PNH marked by the breakdown of red blood cells, which…
Paroxysmal nocturnal hemoglobinuria (PNH) was identified as the likely cause of a stroke in a young man, according to a report from India. While high blood pressure and atherosclerosis, a condition marked by the buildup of fatty deposits inside arteries, are commonly associated with stroke, this case “sheds light…
Epysqli (SB12), a biosimilar of Soliris (eculizumab), is comparable in safety and efficacy for Asian and non-Asian patients with paroxysmal nocturnal hemoglobinuria (PNH). That’s according to a post-hoc analysis of the pivotal Phase 3 SB12 study (NCT04058158), the findings of which supported Epysqli’s approval in the U.S.
Clinical site activation is now ongoing for a Phase 3 program that will evaluate zaltenibart (OMS906) as a treatment for people with paroxysmal nocturnal hemoglobinuria (PNH), its developer Omeros has announced. A total of 120 sites across 30 countries were chosen for clinical trial participation, according to a…
An unusual meningococcal infection during treatment with Empaveli (pegcetacoplan) was reported in a 16-year-old girl with paroxysmal nocturnal hemoglobinuria (PNH), according to a case report from Finland. Meningococcal infections are a known risk for patients receiving complement inhibitors, such as Empaveli. As such, patients typically are vaccinated before…
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