Agios Awaits Pyrukynd Decision in Thalassemia as FDA Misses Due Date

Key Takeaways AGIO says the FDA missed its Dec. 7 deadline for a Pyrukynd thalassemia sNDA decision.The sNDA remains under FDA review but no additional efficacy or safety data have been requested.Pyrukynd is already approved for treating hemolytic anemia in adults with PK deficiency.Agios Pharmaceuticals (AGIO) announced that the FDA has not yet given its decision related to the company’s supplemental new drug application (sNDA) seeking approval for its only marketed drug, Pyrukynd (mitapivat), for treating ...