Acoramidis fda approval

BridgeBio's investigational cardiomyopathy molecule acoramidis Third Alzheimer's Drug Gets FDA Approval, Just as Diagnostic Criteria Expand

In addition to its efforts in ATTR cardiomyopathy, acoramidis is set to be the only oral drug approved in the US for ATTR polyneuropathy, as Vyndaqel failed to gain approval by the FDA for this indication as they required further efficacy studies before granting approval. As acoramidis will likely see approvals in both polyneuropathy and

Acoramidis and vutrisiran have not yet been approved by the FDA for ATTR-CM, and the manufacturers have not announced US prices for each therapy if approved. ICER has calculated a health benefit price benchmark (HBPB) for TTR stabilizers such as tafamidis and acoramidis to be between $13,600 to $39,000 per year.

BridgeBio Pharma is planning to file for FDA approval for acoramidis toward the end of 2024 and in other countries in 2024, Gillmore reported. It will be a huge benefit to patients to have

Acoramidis hydrochloride by BridgeBio Pharma for Familial Amyloid Cardiomyopathy: Likelihood of Approval Acoramidis hydrochloride is under

BridgeBio's acoramidis billed as potential rival to Pfizer's Vyndaqel. FDA approves first Niemann-Pick disease, type C treatment. 20

The Company filed an NDA for acoramidis for the treatment of ATTR-CM with the US FDA; the NDA was accepted for review with a PDUFA date of

Acoramidis, a Potential Best-in-Class TTR Stabilizer, Submitted for FDA Approval

If the change from baseline in 6MWD in Part A is highly statistically significant, BridgeBio expects to submit an application for regulatory approval of acoramidis in 2024 to the FDA.