The FDA’s Endocrinologic & Metabolic Drugs Advisory Committee is meeting today to discuss whether or not previous indications for Abbott’s cholesterol drug fenofibrate (Trilipix) to be co-administered with a statin should be revoked or limited.
The review comes after the results of the ACCORD-Lipid trial showed that adding a statin to fenofibrate did not significantly reduce cardiac events in diabetics.
While Abbott will argue that its drug has a favorable risk-benefit profile, ultimately the decision will rest in the hands of the 13 voting members who will decide whether to: allow continued marketing, withdraw approval for fenofibrate’s indication for coadministration with a statin or allow marketing of the drug with a statin but revise labeling or require an additional clinical trial to be conducted to evaluate the therapy in high-risk patients.
In other drug news, the FDA announced that beginning Nov. 18, physicians will have to enroll in a special program—the Avandia-rosiglitazone Medicines Access Program—to be able to prescribe and receive rosiglitazone (Avandia)-containing medications. The action comes as part of the FDA’s Sept. 23 decision to restrict market use of the drug after it was found that it could have the potential to increase the risk of CV events in patients.
Under the FDA’s Risk Evaluation and Mitigation Strategy (REMS) program, physicians will now have to review prescribing information with patients, sign a prescribed enrollment form and provide a Medication Guide to inform patients of the risks/benefits of rosiglitazone.
“Of science and the human heart there is no limit,” U2 continued to sing in 'Miracle Drug." The news this week leaves us wondering whether there will ever be a “miracle” drug, or if the promise of a polypill that will fix a patient’s cardiac problems without the potential risks. Will the new Avandia restrictions turn more physicians toward administering pioglitazone (Actos) or other alternative drugs because they will fear that class of drugs? Will the FDA send Abbott back to the drawing board to alter drug labels for Trilipix? These questions remain unknown but the industry continues to seek better answers in new miracle drugs.
Senior Writer, Cardiovascular Business