BridgeBio Pharma (NASDAQ:BBIO) Receives FDA Approval for ATTR-CM Treatment ‘Attruby™ (acoramidis)’

On November 22, 2024, BridgeBio Pharma, Inc. (BBIO) announced that its recent drug, Attruby™ (acoramidis), had received approval from the U.S. Food and Drug Administration (FDA) for the treatment of adults with ATTR-CM to reduce cardiovascular death and cardiovascular-related hospitalization. This approval marks a significant milestone for BridgeBio, as Attruby is the first and only approved product with a label specifying near-complete stabilization of TTR (≥90%).

The approval was based on positive results observed in the ATTRibute-CM Phase 3 study, where Attruby demonstrated a substantial reduction in death and cardiovascular-related hospitalization and showed improvement in quality of life for patients. Notably, in the study, Attruby showed the most rapid benefits seen in any Phase 3 study of ATTR-CM to date, with significant reductions in composite all-cause mortality and recurrent cardiovascular hospitalization events observed.

Attruby will be available at a recommended dose of 712 mg, taken twice daily, at a list price of $18,759.12 for a 28-day supply. To support patients, BridgeBio will provide Attruby free for life to U.S. clinical trial participants. The company has also initiated patient support programs to assist in the access and administration of the medication.

In light of this approval, BridgeBio will be receiving a $500 million payment under its royalty funding agreement. The company plans to expand its global reach for Attruby, with the submission of a Marketing Authorization Application to the European Medicines Agency and exclusive rights granted to Bayer for commercialization in Europe.

BridgeBio’s management expressed enthusiasm regarding the FDA approval of Attruby, highlighting the importance of expanding treatment options for patients with ATTR-CM to improve outcomes and quality of life. The company remains committed to its mission of ‘putting patients first’ and aims to continue exploring the full potential of this treatment while pursuing regulatory approvals globally.

For further details on the management remarks and insights on Attruby, investors can access the event calendar page on BridgeBio’s website. While the FDA approval signifies a significant achievement for BridgeBio, it also underscores the company’s dedication to delivering transformative medicines for patients with genetic diseases.

The article is based on BridgeBio Pharma’s recent submission to the U.S. Securities and Exchange Commission under Form 8-K, showcasing the company’s progress with the FDA approval of Attruby™ (acoramidis) for the treatment of ATTR-CM patients.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read BridgeBio Pharma’s 8K filing here.

About BridgeBio Pharma

BridgeBio Pharma, Inc, a commercial-stage biopharmaceutical company, discovers, creates, tests, and delivers transformative medicines to treat patients who suffer from genetic diseases and cancers. Its products in development programs include AG10, a next-generation oral small molecule near-complete TTR stabilizer that is in Phase 3 clinical trial for the treatment of TTR amyloidosis, or transthyretin amyloid cardiomyopathy (ATTR-CM); low-dose infigratinib, an oral FGFR1-3 selective tyrosine kinase inhibitor, which is in Phase 3 double-blinded, placebo-controlled pivotal study for the treatment option for children with achondroplasia; and BBP-631, an AAV5 gene transfer product candidate that is in Phase 1/2 clinical trial for the treatment of congenital adrenal hyperplasia, or CAH, driven by 21-hydroxylase deficiency, or 21OHD.