Novartis has received approval from the US Food and Drug Administration (FDA) for its Jadenu (deferasirox) tablets to treat patients with chronic iron overload.
Chronic iron overload is a life-threatening cumulative toxicity, which results from blood transfusions required to treat sickle cell disease, myelodysplastic syndromes, thalassemia and other conditions.
FDA has approved a new oral formulation for Exjade (deferasirox) tablets to treat chronic iron overload due to blood transfusions in patients two years of age and older and chronic iron overload in non-transfusion-dependent thalassemia syndromes (NTDT) in patients ten years of age and older.
Novartis oncology president Bruno Strigini said: “Novartis has had a long-term commitment to improving the lives of patients with chronic iron overload. “Novartis has had a long-term commitment to improving the lives of patients with chronic iron overload.”
“Exjade transformed iron chelation therapy. We responded to feedback from patients and their physicians, and now Jadenu, by simplifying treatment administration, offers an important new option to help meet these patients’ needs.”
According to the company, the indications are approved under accelerated approval based on a reduction of iron levels in the liver and blood.
The company has also submitted additional regulatory applications for Jadenu in other countries across the globe.
Novartis has established a multi-year collaboration with Aduro Biotech to discover and develop new cancer immunotherapies targeting the stimulator of interferon genes (STING) pathway and launched a new immuno-oncology research group led by cancer vaccine expert Dr Glenn Dranoff.
Under the deal, Aduro will receive an upfront payment of $200m from Novartis. Aduro will secure an initial equity investment of $25m, in addition to another $25m equity investment in the future.