A pregnant woman with paroxysmal nocturnal hemoglobinuria (PNH) and an inherited blood clotting disorder had a successful and uneventful pregnancy after receiving tailored treatment with Soliris (eculizumab) and anti-clotting therapy. “With the combined expertise of hematologists and obstetricians, comprehensive care can be provided to pregnant women with PNH, minimizing the…
News
The U.S. Food and Drug Administration (FDA) has approved Epysqli (eculizumab-aagh), a Soliris (eculizumab) biosimilar, to prevent red blood cell destruction (hemolysis) in patients with paroxysmal nocturnal hemoglobinuria (PNH). Biosimilars contain a version of the active ingredient of an approved biological therapy — a treatment that uses substances…
A 43-year-old woman with paroxysmal nocturnal hemoglobinuria (PNH) who experienced extravascular hemolysis — which occurs when red blood cells are destroyed or broken down outside of the blood vessels — despite previous treatment saw her condition significantly improve after initiating treatment with Fabhalta (iptacopan), according to a case…
Using Empaveli (pegcetacoplan) during a new pregnancy led to a healthy outcome for a mother and her baby boy, even though complications of paroxysmal nocturnal hemoglobinuria (PNH) arose. The mother, who previously had two miscarriages and a poor response to Soliris (eculizumab), recovered from an episode of…
Most of the adults with paroxysmal nocturnal hemoglobinuria (PNH) who switched from Soliris (eculizumab) to PiaSky (crovalimab) in a clinical trial said they preferred PiaSky because it was easier to use, required fewer hospital visits, and took less time to administer. That’s according to data from…
A European Medicines Agency (EMA) committee has recommended the approval of Roche’s PiaSky (crovalimab) to treat people with paroxysmal nocturnal hemoglobinuria (PNH), ages 12 and older, who weigh at least 40 kilograms (88 pounds) — including patients both new to, or previously treated with, C5 inhibitors. The news…
The U.S. Food and Drug Administration (FDA) has approved crovalimab — which works to reduce the destruction of red blood cells in paroxysmal nocturnal hemoglobinuria (PNH) — to treat teenagers and adults with PNH. The therapy, which won formal approval from the FDA on June 20, is…
Soliris (eculizumab) was successfully used to help manage paroxysmal nocturnal hemoglobinuria (PNH) during a pregnancy in two women. Based on observations made in these cases, the scientists noted that Soliris “seems to be generally safe in pregnancy for both mother and fetus,” though they emphasized a need for additional…
Epysqli (SB12), a biosimilar of Soliris (eculizumab), is as effective as the reference therapy in reducing the need for blood transfusions in patients with paroxysmal nocturnal hemoglobinuria (PNH). That’s according to a post-hoc analysis of the pivotal Phase 3 SB12 study (NCT04058158), whose findings supported Epysqli’s approval in…
The U.S. Food and Drug Administration (FDA) has approved Bkemv (eculizumab-aeeb), the first interchangeable biosimilar of Soliris (eculizumab), to treat people with paroxysmal nocturnal hemoglobinuria (PNH). Soliris is an intravenous (into-the-vein) antibody-based therapy that is approved to reduce hemolysis, or red blood cell destruction, in PNH patients. As…
Recent Posts
- New questionnaire assessing fatigue ‘reliable and valid’ for adults with PNH
- Progress in research and treatments is a reason for holding on to hope
- New gene study highlights clot risk factor in people living with PNH
- Becoming a patient advocate gave me purpose in the fight against PNH
- Study finds Ultomiris safe as PNH treatment during pregnancy