This approval follows a recommendation for conditional approval issued in July by the European Medicines Agency’s Committee for Medicinal Products for Human Use. Adakveo is now the first targeted SCD therapy to be approved in the European Union to prevent VOCs. It was approved for the same indication last year by the FDA in the U.S.
The approval covers the use of Adakveo in combination with hydroxyurea (also known as hydroxycarbamide) — another approved therapy for SCD — and as a stand-alone therapy in patients for whom hydroxyurea treatment is inappropriate.
Sickle cell disease is considered a rare blood condition, affecting about 50,000 people in Europe. “Data shows that nine out of ten people living with sickle cell disease experience one or more VOCs in a year, with a third of those crises leading to hospitalization, underscoring the significant unmet need among a vulnerable group of patients,” said Kees Roks, Head Region Europe, Novartis Oncology. “Just one VOC could be catastrophic for the patient, so preventing these sudden, unpredictable and life-threatening events is hugely important. Today’s decision gives people living with sickle cell disease a chance to achieve that goal.”
Adakveo (crizanlizumab) binds to P-selectin, a cell adhesion protein that plays a central role in the multicellular interactions that can lead to vaso-occlusion. It can be given as an add-on therapy to HU/HC or as monotherapy in patients for whom HU/HC is inappropriate or inadequate.
It is the first and only targeted biologic that works by binding to P-selectin, a cell adhesion protein that plays a central role in the multicellular interactions that can lead to vaso-occlusion in sickle cell disease. By binding to P-selectin on the surface of the activated endothelium and platelets, Adakveo blocks interactions between endothelial cells, platelets, red blood cells, and leukocytes.
Adakveo is now approved in 36 countries around the world including the United States and European Union member states.
Read the Full Novartis’ Press Release on Adakveo’s EU Approval HERE