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.
Soliris (eculizumab) has been approved in the European Union (EU) for expanded use to include the treatment of refractory generalised myasthenia gravis (gMG) in children and adolescents aged six to 17 years who are anti-acetylcholine receptor (AChR) antibody-positive (Ab+). This is the first and only targeted therapy approved for the treatment of paediatric patients with the disease in the EU.
Amgen`s Bekemv (eculizumab) Approved In Europe
Soliris (eculizumab) has been recommended for marketing authorisation in the European Union (EU) for expanded use to include the treatment of refractory generalised myasthenia gravis (gMG) in children and adolescents aged six to 17 years who are anti-acetylcholine receptor (AChR) antibody-positive (Ab+). If authorised, Soliris would be the first and only targeted therapy approved for the treatment of paediatric patients aged six years and older with refractory gMG in the EU.
UK-based biopharmaceutical company AstraZeneca has announced that the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorisation for Soliris (eculizumab). The authorisation would include refractory generalised myasthenia gravis (gMG) in children aged six to 17 who are anti-acetylcholine receptor (AChR) antibody-positive (Ab+).