Agios Announces FDA Orphan Drug Designation Granted to Tebapivat (AG-946) for ... - Stock Titan
Agios Pharmaceuticals received FDA orphan drug designation for tebapivat (AG-946) in MDS treatment, aiming to be the first oral therapy for anemia in lower-risk MDS, affecting 75,000-80,000 patients in the U.S. and EU5. The designation offers tax credits and potential market exclusivity, with Agios completing a Phase 2a study and initiating a Phase 2b study.
Related Clinical Trials
Highlighted Terms
Related News
Agios Pharmaceuticals received FDA orphan drug designation for tebapivat (AG-946) in MDS treatment, aiming to be the first oral therapy for anemia in lower-risk MDS, affecting 75,000-80,000 patients in the U.S. and EU5. The designation offers tax credits and potential market exclusivity, with Agios completing a Phase 2a study and initiating a Phase 2b study.
Tebapivat, a novel PK activator, received orphan drug designation from the FDA for treating anemia in lower-risk MDS. A phase 2b study is evaluating tebapivat, aiming for transfusion independence in anemia-affected MDS patients.
The FDA granted orphan drug designation to tebapivat (AG-946) for treating myelodysplastic syndromes (MDS). Tebapivat is being studied in a phase 2 trial for anemia in lower-risk MDS, with phase 2a data showing 4 out of 10 low transfusion burden patients achieving transfusion independence. The phase 2b study will continue to evaluate tebapivat in patients with lower-risk MDS, focusing on transfusion independence as the primary endpoint.
Agios Pharmaceuticals received orphan drug designation (ODD) from the FDA for tebapivat to treat myelodysplastic syndromes (MDS). The designation offers benefits like tax credits, fee exemptions, and market exclusivity. Agios aims to deliver the first oral therapy addressing anaemia in lower-risk MDS, affecting around 75,000-80,000 patients in key markets. The company focuses on developing therapies for rare diseases, with lead asset mitapivat, a PK activator, previously receiving ODD for PK deficiency, thalassaemia, and sickle cell disease.
Agios Pharmaceuticals announced FDA orphan drug designation for tebapivat, its PK activator, for treating myelodysplastic syndromes (MDS). The designation aims to provide new oral treatment options for MDS patients, affecting 75,000-80,000 in the U.S. and EU5. Agios completed a Phase 2a study and is initiating a Phase 2b study for tebapivat in lower-risk MDS.
Agios Pharmaceuticals announced FDA orphan drug designation for its PK activator tebapivat in treating myelodysplastic syndromes (MDS). The designation supports development for rare disorders affecting fewer than 200,000 people in the U.S., offering incentives like tax credits and potential market exclusivity. Agios aims to deliver the first oral therapy addressing anemia in lower-risk MDS, currently in Phase 2b study.