FDA clears new indication for Promacta
The Food and Drug Administration has expanded the use of Promacta (eltrombopag) to include first-line treatment for adults and pediatric patients age 2 years old and older with severe aplastic anemia, or SAA, in combination with standard immunosuppressive therapy, or IST.
Promacta is an oral thrombopoietin receptor agonist that is already approved for SAA for patients who have had an insufficient response to IST. It also is approved for adults and children with chronic immune thrombocytopenia who are refractory to other treatments, and for the treatment of thrombocytopenia in patients with chronic hepatitis C virus, or HCV infection.
"Severe aplastic anemia can be a fatal diagnosis if left untreated, and many patients fail to respond to current initial treatment options," Novartis Oncology CEO Liz Barrett said. "Today's U.S. approval for Promacta is an important step forward for people living with this challenging disease and shows how Novartis continues to reimagine care in areas where few treatment options exist."
SAA is a rare, life-threatening, acquired blood disorder in which a patient's bone marrow fails to produce enough red blood cells, white blood cells and platelets. As a result, people living with this serious disease may experience such debilitating symptoms and complications as fatigue, trouble breathing, recurring infections, and abnormal bruising or bleeding that can limit their daily activities.
The FDA also granted Promacta Breakthrough Therapy designation as a countermeasure for hematopoietic sub-syndrome of acute radiation syndrome, or radiation sickness, which occurs after exposure to ionizing radiation and leads to many symptoms including thrombocytopenia.
Promacta is an oral thrombopoietin receptor agonist that is already approved for SAA for patients who have had an insufficient response to IST. It also is approved for adults and children with chronic immune thrombocytopenia who are refractory to other treatments, and for the treatment of thrombocytopenia in patients with chronic hepatitis C virus, or HCV infection.
"Severe aplastic anemia can be a fatal diagnosis if left untreated, and many patients fail to respond to current initial treatment options," Novartis Oncology CEO Liz Barrett said. "Today's U.S. approval for Promacta is an important step forward for people living with this challenging disease and shows how Novartis continues to reimagine care in areas where few treatment options exist."
SAA is a rare, life-threatening, acquired blood disorder in which a patient's bone marrow fails to produce enough red blood cells, white blood cells and platelets. As a result, people living with this serious disease may experience such debilitating symptoms and complications as fatigue, trouble breathing, recurring infections, and abnormal bruising or bleeding that can limit their daily activities.
The FDA also granted Promacta Breakthrough Therapy designation as a countermeasure for hematopoietic sub-syndrome of acute radiation syndrome, or radiation sickness, which occurs after exposure to ionizing radiation and leads to many symptoms including thrombocytopenia.