Samsung Bioepis Presents Post-hoc Analysis of Phase 3 Study for EPYSQLI™ (SB12; Eculizumab Biosimilar), at the European Hematology Association (EHA) Congre
Post-hoc analysis of Phase 3 study to highlight transfusion avoidance results of SB12 compared to reference eculizumab-treated groups INCHEON, Korea, May 30, 2024 (GLOBE NEWSWIRE) -- Samsung...
US FDA approves Amgen`s biosimilar to AZ`s rare blood disorder treatment
SILVER SPRING, Md., May 28, 2024 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab) to treat certain rare diseases. Bkemv is approved for the following treatment indications, which are also currently approved for Soliris:
The Subject Expert Committee (SEC), that advises the Central drug regulator regarding clinical trials and approvals of drugs, has recommended for grant of approval for import and market of AstraZeneca Pharma's eculizumab concentrate for solution for infusion 300 mg, branded as Soliris in US, for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) subject to certain condition.
Voydeya (danicopan) has been approved in the European Union (EU) as an add-on to ravulizumab or eculizumab for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who have residual haemolytic anaemia.1 Voydeya is a first-in-class, oral, Factor D inhibitor developed as an add-on to standard-of-care Ultomiris (ravulizumab) or Soliris (eculizumab) to address the needs of the approximately 10-20% of patients with PNH who experience clinically significant extravascular haemolysis (EVH) while treated with a C5 inhibitor.2,3
Voydeya recommended for approval in the EU by CHMP
Alexion Pharma`s Biologic Soliris (eculizumab) Receives Approval in the U.S.
PIII trial data showed danicopan as add-on to ULTOMIRIS sustained improvements
Soliris (eculizumab) has been approved in Japan for expanded use to include the treatment of generalised myasthenia gravis (gMG) in paediatric patients who are anti-acetylcholine receptor (AChR) antibody-positive and whose symptoms are difficult to control with high-dose intravenous immunoglobulin (IVIG) therapy or plasmapheresis (PLEX). Soliris is the first and only targeted therapy approved for the treatment of children and adolescents with gMG in Japan.