Mitapivat
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NOVITÀ
EHA2022 | Agios Presents New Data Supporting the Benefits of PYRUKYND®In Adults With PKD
Data were presented at the European Hematology Association (EHA) Annual Congress, hosted virtually and in person in Vienna on June 9-12, 2022. “Following the FDA approval of PYRUKYND® for the treatment…
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NOVITÀ
PYRUVATE KINASE DEFICIENCY | FDA Approves First Drug For The Rare Inherited Anemia
The US Food and Drug Administration (FDA) has announced the approval of Mitapivat (PYRUKYND®) tablets as treatment for haemolytic anemia in adults with pyruvate kinase (PK) deficiency. The oral PK…
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NOVITÀ
MITAPIVAT | FDA Grants Priority Review To New Drug For Pyruvate Kinase Deficiency
The NDA was granted a Priority Review designation and has been given a Prescription Drug User Fee Act (PDUFA) action date of February 17, 2022, accelerating the review time from…
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NOVITÀ
PYRUVATE KINASE DEFICIENCY | Agios Submits New Drug Application To FDA For Mitapivat
“With this NDA filing, we are poised to deliver the first potentially disease-modifying therapy for people with PK deficiency, a chronic, lifelong haemolytic anaemia characterized by serious complications affecting multiple…
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NOVITÀ
FDA Grants Orphan Drug Designation to Mitapivat for Treatment of Thalassaemia
Agios Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to the company’s first-in-class pyruvate kinase-R (PKR) activator Mitapivat for the treatment of…
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