This question has been on my mind for years. I keep checking the FDA website with no luck to confirm. Below is my email exchange of today with the FDA.
Even though the FDA publishes a list of FDA BTD Approvals (which has NOT and does NOT currently list apabetalone), The FDA will not confirm or deny that Apabetalone has been granted this designation.
Dear Xxxx,
Thank you for writing the Division of Drug Information in the FDA's Center for Drug Evaluation and Research.
Please review the links provided on Frequently Asked Questions: Breakthrough Therapies.
Please know, under the law (21 CFR 314.430), FDA cannot divulge information related to drug applications that may or may not have been submitted to the Agency. Information about a drug that has not yet been approved is subject to strict confidentiality laws and belongs to the sponsor.
Best regards,
CW
Pharmacist
Division of Drug Information
Center for Drug Evaluation and Research
Tel: 855-543-DRUG (855-543-3784)
druginfo@fda.hhs.gov
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This communication is consistent with 21 CFR 10.85(k) and constitutes an informal communication that represents our best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of the FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.
--------------- Original Message ---------------
From: Xxxx]
Sent: 6/13/2023 12:56 PM
To: druginfo@fda.hhs.gov
Subject: FDA Breakthrough Therapy Designation List
Dear Sir/Madam:
Could you please direct me to the site where I may find a complete list of drugs that have in the past received the FDA Breakthrough Therapy Designation?
Could you also please confirm whether or not, and if so when, the FDA has granted a Breakthrough Therapy Designation to the drug named Apabetalone (RVX-208) that is being studied for cardio-vascular disease by Resverlogix Corp?
Thank you.
Regards,
Xxxx
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