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…
Long-term treatment with KP104, a first-in-class dual-function complement inhibitor, controlled red blood cell destruction occurring both inside and outside the blood vessels of people with paroxysmal nocturnal hemoglobinuria (PNH), according to data from a Phase 2 trial. Based on these findings, Kira Pharmaceuticals, its developer,…
An intensive dosing regimen of Empaveli (pegcetacoplan) effectively managed events of acute red blood cell destruction, called hemolysis, in people with paroxysmal nocturnal hemoglobinuria (PNH), according to an ongoing clinical study’s interim data. Also, the intensive regimen was found to be safe and well tolerated in these patients,…
Dawn Health, a Danish digital health company, and Novartis have launched a smartphone app designed to help people living with paroxysmal nocturnal hemoglobinuria (PNH) with disease management. The free Ekiva PNH app helps patients track their symptoms and prepare for medical appointments, while also providing a…
The oral therapy Voydeya (danicopan) is now approved in the European Union as an add-on treatment for paroxysmal nocturnal hemoglobinuria (PNH). The European Commission authorized the therapy for adults with PNH who have residual hemolytic anemia — that is, low counts of red blood cells because those…
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