Treats cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM). NDA 216540, held by Bridgebio Pharma. Acoramidis Hydrochloride.
As of Nov 13, 2026, NDA 216540 (Attruby), held by Bridgebio Pharma, was first approved by FDA on Nov 22, 2024, with 0 approved supplements and 0 published complete response letters.
ATTRUBY is indicated for the treatment of the cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular death and cardiovascular-related hospitalization.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 22, 2024 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| AttrubyEQ 356MG BASE · tablet;oral | Acoramidis Hydrochloride | RxReference drug |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
