Agios Announces FDA Approval of PYRUKYND® (mitapivat) as - GlobeNewswire
The FDA approved PYRUKYND® (mitapivat) for treating hemolytic anemia in adults with pyruvate kinase (PK) deficiency, based on ACTIVATE and ACTIVATE-T Phase 3 studies. Agios offers patient access programs, including $0 copays and free medication for eligible patients. PYRUKYND® is the first disease-modifying therapy for PK deficiency.
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The FDA approved PYRUKYND® (mitapivat) for treating hemolytic anemia in adults with pyruvate kinase (PK) deficiency, based on ACTIVATE and ACTIVATE-T Phase 3 studies. Agios offers patient access programs, including $0 copays and free medication for eligible patients. PYRUKYND® is the first disease-modifying therapy for PK deficiency.
FDA approved Agios Pharmaceuticals' Pyrukynd for treating haemolytic anaemia in adults with PK deficiency, marking the first disease-modifying therapy for this condition. Based on Phase III trials, Pyrukynd showed significant improvements in haemoglobin levels and reduced transfusion burden. Agios plans further studies and aims for broad patient access, with no price increase for five years.
FDA approved Agios Pharmaceuticals' mitapivat (Pyrukynd) for pyruvate kinase deficiency, a rare anemia, marking a shift to focus on blood diseases. Priced at $335,000 annually, it aims to treat more rare blood disorders. Agios plans expansion, despite high costs and slow market rollout expectations.