Monday, January 25, 2021
The Menarini Group, a privately-held Italian pharmaceutical and diagnostic company, announced that it has been granted marketing authorization by the European Commission for ELZONRIS (tagraxofusp) as a monotherapy for the first-line treatment of adult patients with plasmacytoid blast dendritic cell neoplasm (NCDPB), an aggressive hematologic malignancy with adverse consequences. The Commission's decision follows the positive opinion issued in November 2020 by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in November 2020, and is based on the largest clinical trial prospective study never carried out on patients
ELZONRIS has achieved orphan drug designation in Europe and becomes the first treatment approved for patients with NCDPB, the first approved treatment targeting CD123, as well as the first treatment to address these unmet medical needs, in Europe .
“For the first time, European patients with NCDPB will have the opportunity to receive treatment tailored to this aggressive disease,” said Elcin Barker Ergun , CEO of the Menarini Group. The approval of ELZONRIS will significantly change the therapeutic approach to the treatment of NCDPB, as it gives clinicians access to targeted therapy to help patients suffering from this terrible disease. We are currently working to make ELZONRIS available to European doctors as quickly as possible, in line with our commitment to provide innovative and effective medicines to people with serious health problems. "
ELZONRIS is a targeted therapy on CD123 approved by the Food and Drug Administration (FDA) and marketed in the United States since 2019 by Stemline Therapeutics, now part of the Menarini group of companies.
ELZONRIS was approved by the FDA in 2018 in the United States, where it is currently available for the treatment of NCDPB in adults and children two years of age or older.