Takeda Gets Positive CHMP Opinion For Recombinant ADAMTS13 In Congenital Thrombotic Thrombocytopenic Purpura

Author: Benzinga Newsdesk | May 31, 2024 09:59am

cTTP Is an Ultra-rare, Potentially Fatal Blood-Clotting Disorder with Limited Treatment Options; Untreated, Acute TTP Events Have a Mortality Rate of >90%1,2
If Approved in the European Union, rADAMTS13 Will Be the First and Only Recombinant ADAMTS13 Enzyme Replacement Therapy for cTTP
Positive Opinion Based on Totality of Evidence, Including Results from the First Randomized, Controlled, Open-label, Crossover Phase 3 cTTP Trial

Takeda ((TAK) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval, under exceptional circumstances, of recombinant ADAMTS13 (rADAMTS13) for the treatment of ADAMTS13 deficiency in children and adult patients with cTTP. The European Commission (EC) will consider the CHMP positive opinion when determining the potential marketing authorization for rADAMTS13 throughout the European Union (EU). If approved, rADAMTS13 will be the first and only enzyme replacement therapy in the EU for the treatment of cTTP.3

Posted In: TAK