FDA liver injury warning label for Agios' Pyrukynd

The US Food and Drug Administration (FDA) approved an update to the US Prescribing Information (USPI) for Pyrukynd (mitapivat) for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency, Agios Pharmaceutical (Nasdaq: AGIO) revealed in a Security and Exchange Commission (SEC) notice.

The revised label now requires liver function tests prior to the start of treatment and monthly monitoring for the first six months. The update follows observations of liver injury in patients given a higher dose than the one approved for PK deficiency. Those events were characterised by ALT levels rising to >5 times the upper limit of normal within the first six months, sometimes accompanied by jaundice.

The news was discounted by investors, as Agios’ share closed up 4.2% at $33.54 following the announcement.