Drugs

FDA Grants, Denies Fenofribrate Petition

FDA has granted in part and denied in part a 4/2024 petition submitted by Healthy Women concerning the class labeling of fenofibrates and pemafibrate clinical data. The agency’s 6/6 response says Healthy Women asked FDA to:

revise the labeling for all currently approved fenofibrate drugs to (a) remedy a misimpression among healthcare professionals that fenofibrates, when used alone or in combination with statins, reduce cardiovascular risk, and the resulting improper use of fenofibrates and (b) incorporate new related information from the recently published PROMINENT study; and
take further action to ensure the information is expeditiously communicated to healthcare professionals and patients.

The petition also provided specific proposed label wording.

The letter says FDA granted the petition insofar as it has approved labeling changes described in its response and denied the remainder.

FDA says it agrees that the notion that statin-treated patients may benefit from the addition of fenofibrate is not scientifically justified and agrees that labeling changes for fenofibrates to incorporate information from the PROMINENT trial, which studied pemafibrate, is appropriate.

It says that since the date of the petition, the agency has approved labeling changes for all branded fenofibrate drugs and expects that any generics will incorporate the changes. “Although the labeling changes reflected in the recently revised labeling of fenofibrates differ, in certain respects, from the exact text and sections of labeling requested, we believe the recently revised labeling appropriately incorporates the concerns and information raised in your petition,” FDA says.

FDA says it has determined that a Dear Healthcare Professional letter and a drug safety communication as requested in the petition are not necessary in this circumstance. “FDA has already communicated via several methods and has taken multiple actions since 2007 to inform prescribers and the public that multiple clinical trials have failed to establish effectiveness of fenofibrate as monotherapy and in combination with a statin for providing any cardiovascular benefit,” the letter says.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome