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When Will Takeda Pharmaceuticals’ Orphan Drug Adcetris Be Launched in Europe ?

November 23, 2012

      Per the National Electronic Library for Medicines (NELM) in the UK, a personal communication from Takeda Pharmaceuticals on November 14, 2012, announces the UK launch of Adcetris (Brentuximab vedotin) for the treatment of Hodgkin Lymphoma (HL) and systemic anaplastic large cell lymphoma (sALCL). The recommended dose is administered as an intravenous infusion over 30 minutes every 3 weeks. The NHS list price for Adcetris is £2500 per 50mg single use vial. This may mark the start of the European roll-out for Adcetris.      

      Takeda Pharmaceuticals and Seattle Genetics’ orphan drug Adcetris (brentuximab vedotin) has the following history in Europe :  

  1. On January 15, 2009, EMA’s CHMP gives orphan drug designation for treatment of Hodgkin Lymphoma (HL) and systemic anaplastic large cell lymphoma (sALCL)   
  2. On July 19, 2012, receives from EMA’s CHMP a positive opinion, recommending the granting of a conditional marketing authorization for HL and sALCL
  3.  On October 25, 2012, EC grants a marketing authorization valid throughout the EU for Adcetris.

        Adcetris has the following history in the United States: 

  1. On October 23, 2008, receives FDA Orphan Drug Designation (ODD) for sALCL.  On August 19, 2011, receives FDA orphan approval & exclusivity start date for sALCL
  2. On January 30, 2007, receives FDA ODD for HL.  On August 19, 2011, receives FDA orphan approval & exclusivity start date for HL. 

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