First-in-Class Cholesterol Drug to Be Consider by FDA Committee

New ACC/AHA Guidelines -- Part Three: Controversies Surrounding New Cholesterol Guidelines
First-in-Class Cholesterol Drug to Be Consider by FDA Committee

On Tuesday the Endocrinologic and Metabolic Drugs Advisory Committee of the Food and Drug Administration (FDA) will meet to decide if the investigational drug alirocumab should be recommended for approval. A Briefing Document posted to the FDA website states that alirocumab significantly lowered low-density lipoprotein cholesterol (LDL-C) from baseline relative to the comparators in ten double-blind, randomized Phase 3 trials.

In addition to weighing recommendation of the drug approval, the Advisory Committee will assess for which populations, if any, do the LDL-C-lowering benefits of alirocumab exceed its risks to support approval (ie, different degrees of cardiovascular risk, familial vs. non-familial etiologies of hyperlipidemia, use with or without concomitant statins, etc.). In the Briefing Document the Advisory Committee highlight that they will review whether or not the drug should be indicated for patients who are “statin-intolerant,” as many patients who are not able to take statins may not actually be intolerant of the pharmacological drug class.

Alirocumab is an investigational monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) that is administered subcutaneously. In January it received Priority Review from the FDA. If approved, it would be the first PCSK9 inhibitor indicated for hypercholesterolemia. The Advisory Committee recommendation is non-binding and will be considered by the FDA.

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