Category: Clinical Trials

BREAKING NEWS: The U.S. Food and Drug Administration has approved BridgeBio’s Attruby™ (acoramidis) for the treatment of patients with transthyretin amyloid cardiomyopathy (ATTR-CM).

Exciting news for patients with ATTR-CM (transthyretin amyloid cardiomyopathy): the FDA has approved Attruby (acoramidis), offering a new treatment option for those affected by this serious disease. The FDA approval is based on positive results seen in the ATTRibute-CM Phase 3 study, where Attruby significantly reduced death and cardiovascular-related hospitalization, and improved quality of life.

What is ATTR-CM?

ATTR-CM is a rare and progressive disease where a protein called transthyretin (TTR) misfolds and forms harmful amyloid deposits in the heart. Over time, these deposits can lead to heart failure, making it difficult for the heart to pump blood properly. Although treatments for ATTR-CM have been limited, the approval of Attruby offers new hope for patients affected by this debilitating disease.

What is Attruby?

Attruby is a drug that acts as TTR stabilizer. Attruby works by binding to the TTR protein and helping to stabilize that protein structure, preventing it from breaking down, misfolding, and forming amyloid fibrils. By stabilizing TTR and reducing the rate at which TTR misfolds, Attruby has the potential to limit amyloid formation and subsequently slow the progression of the disease.

Why This Approval Matters

The FDA’s approval of Attruby is significant for patients with ATTR-CM, providing them with another effective treatment option. With two FDA-approved therapies now available for ATTR-CM — Attruby and Vyndamax/Vyndaqel (also a TTR stabilizer) — patients and their doctors can work together to choose the treatment that best meets their needs, ultimately improving heart health and quality of life.

“The FDA approval of Attruby (acoramidis) is a significant milestone for patients with ATTR-CM, offering a much-needed additional treatment option alongside Vyndamax/Vyndaqel. This new therapy provides more choices for patients and healthcare providers, helping to better manage this challenging disease. We’re hopeful that Attruby will improve outcomes and bring greater hope to those living with ATTR-CM.”

— Kristen Hsu, Executive Director of Research, ARC

How Can Patients Access Attruby?

If you’ve been diagnosed with ATTR-CM, speak with your healthcare provider to find out if Attruby is the right treatment for you.

Special Support for Clinical Trial Participants

For those who participated in the clinical trials for acoramidis (Attruby), there is exceptional news: BridgeBio is offering free access to Attruby for life to these patients in the US. This commitment ensures that those who helped bring this treatment to market will continue to receive the medication without any cost for as long as they need it.

BridgeBio’s Patient Support Program: ForgingBridges™

To further assist patients in accessing treatment, BridgeBio has launched the ForgingBridges™ program, a comprehensive support service for those in the U.S. prescribed Attruby. This program provides:

• Insurance resources to help patients navigate coverage options
• Financial assistance options to help reduce out-of-pocket costs
• A dedicated support team to guide patients through their treatment journey

The ForgingBridges™ program is designed to ensure that patients can access Attruby, regardless of their financial situation or insurance coverage. For more information, visit ForgingBridges.com or call 1-888-55-BRIDGE (1-888-552-7434).

Disclaimer: Always consult with your healthcare provider before starting any new treatment.

Download ARC’s Attruby™ (acoramidis) fact sheet here.

Learn about hereditary ATTR amyloidosis here.

Learn about wild-type ATTR amyloidosis here.