Enforcement Action Update: OPDP Issues First Untitled Letter of 2023

June 20, 2023

By Porzio Life Sciences

The Office of Prescription Drug Promotion (“OPDP”) of the U.S. Food and Drug Administration (“FDA”) has issued the first Untitled Letter of 2023 to Xeris Pharmaceuticals, Inc. (“Xeris”) regarding violative webpages for Recorlev (levoketoconazole),  entitled “What is Recorlev®?” and “Taking Recorlev®.” 

According to OPDP, the “What is Recorlev®?” webpage misleadingly overstates the efficacy of Recorlev with claims such as, “67% of patients who moved on to the second part of the study had normal cortisol levels by the end of the study.” OPDP acknowledges that the PI states, 67% of patients in the SONICS study had normal cortisol levels at the end of the titration phase; however, OPDP explains, the titration phase was not the “end of the study,” and the presentation omits material information necessary to interpret the study results from the SONICS study.  Additionally, the claim "More patients who were on a stable and steady dose of Recorlev had normal cortisol levels", according to OPDP, provided a misleading impression regarding the general experience of patients with the drug. The Agency also takes issue with Xeris’ presentation of risk, notably “Side effects can occur with Recorlev, including some that are serious,” indicating Xeris minimizes serious and significant risks of the drug, and does not prominently display the drug’s boxed warning or specific potential side effects, including potentially fatal ones.  

A copy of the Untitled Letter is available here.

For more information regarding FDA enforcement, please see the OPDP Promotional Violations section of the Enforcement Actions Database.  

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