Bkemv (eculizumab-aeeb) — a biosimilar of Soliris (eculizumab) that was approved in the U.S. earlier this year as a treatment for paroxysmal nocturnal hemoglobinuria (PNH) — shows equivalent safety and efficacy to its reference drug, according to newly published data from a Phase 3 clinical trial. Results…
The European Commission has approved Roche’s PiaSky (crovalimab) to treat adults and adolescents with paroxysmal nocturnal hemoglobinuria (PNH), ages 12 and older who weigh at least 40 kilograms (88 pounds). PiaSky is the first treatment for PNH in the European Union that’s administered subcutaneously (under the skin) once a…
Increasing dosing of Empaveli (pegcetacoplan) followed by co-administering Soliris (eculizumab) effectively managed acute red blood cell destruction in a woman with paroxysmal nocturnal hemoglobinuria (PNH), a study shows. The effort underscores how acute red blood cell destruction “requires prompt diagnosis and treatment to avoid potentially…
Health Canada has approved the oral therapy Voydeya (danicopan) as an add-on to Ultomiris (ravulizumab) or Soliris (eculizumab) in adults with paroxysmal nocturnal hemoglobinuria (PNH) who have residual anemia due to blood cell destruction taking place outside blood vessels. The announcement came just a few months…
The specialty pharmacy Onco360 was selected to supply PiaSky (crovalimab-akkz), an antibody-based medication that works to reduce red blood cell destruction, to teenagers and adults with paroxysmal nocturnal hemoglobinuria (PNH). Marketed by Genentech (a Roche subsidiary) in the U.S., the treatment was recently approved by…
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…
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…
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