Company: AGIO
Filing Date: 2025-01-06
Form Type: 8-K
Source: 0001193125-25-001809
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Company: AGIOS PHARMACEUTICALS, INC.
Filing Date: 2025-01-06
Form: 8-K
Item: Item 7.01
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Item 7.01.      Regulation FD.  

On January 3, 2025, the U. S. Food and Drug Administration approved an update to the U. S. Prescribing Information (“ USPI”) for PYRUKYND®(mitapivat) for the treatment of hemolytic anemia in adults with pyruvate kinase (“ PK”) deficiency. The “ Warnings and Precautions” and “ Adverse Reactions” sections of the USPI will now include information regarding liver injury observed in patients with another condition. The “ Warnings and Precautions” section of the USPI now states that:

  in patients with another condition treated with PYRUKYND at a higher dose than that recommended for patients with PK deficiency, liver injury has been observed;  
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  these events were characterized by a time to onset within the first 6 months of treatment with peak elevations of alanine aminotransferase of >5 times the upper limit of normal (“ ULN”) with or...  
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  all patients discontinued treatment with PYRUKYND, and these events improved upon treatment discontinuation.  

The “ Warnings and Precautions” section further instructs prescribers to obtain liver tests prior to the initiation of PYRUKYND and monthly thereafter for the first 6 months and as clinically indicated, to interrupt PYRUKYND if clinically significant increases in liver tests are observed or alanine aminotransferase is >5 times the ULN, and to discontinue PYRUKYND if hepatic injury due to PYRUKYND is suspected.

The “ Adverse Reactions” section of the USPI now refers to hepatocellular injury in another condition and refers readers to the updated “ Warnings and Precautions” section described above.

The information in this Item 7.01 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “ Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in