Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced receiving another indication approval from the National Medical Products Administration (NMPA) for its Revolade (eltrombopag olamine tablets). The oral thrombopoietin receptor agonist can now be used to treat severe aplastic anemia (SAA) in patients with inadequate previous remission following immunosuppressive therapy.
Revolade: Background and Previous Approvals
Revolade was first approved for marketing in the US in 2008 and was approved in China in 2018 for the treatment of chronic immune (idiopathic) thrombocytopenia (ITP) in adults and children aged six and over who do not respond to glucocorticoids and immunoglobulins. The drug is used to increase platelet count and reduce or prevent bleeding.
Severe Aplastic Anemia: Disease Overview
Severe aplastic anemia (SAA) is a bone marrow hematopoietic failure characterized by a severe reduction of whole blood cells. Due to neutropenia and extreme thrombocytopenia, SAA patients are extremely vulnerable to life-threatening anemia, hemorrhage, and infection. While standard immunosuppressive therapy can achieve partial or complete hematological remission in 60% to 70% of severe/extremely severe patients, 30% to 40% of these patients still face the risk of infection and bleeding and rely on blood product infusions.
Strategic Implications
The expanded approval of Revolade for SAA represents a significant advancement in the treatment options available for patients with this rare and severe condition. By addressing the unmet needs of patients who do not respond adequately to immunosuppressive therapy, Novartis is poised to improve patient outcomes and enhance its position in the hematological market. This approval further demonstrates Novartis’ commitment to developing innovative therapies for serious blood disorders.-Fineline Info & Tech
