The U.S. Food and Drug Administration (FDA) has granted approval to BridgeBio Pharma's new drug, Attruby, for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM), a rare and progressive heart condition. This approval marks a significant milestone for BridgeBio, as Attruby becomes the first new treatment for ATTR-CM in over five years, entering a market previously dominated by Pfizer's Vyndaqel.

ATTR-CM is a condition where unstable proteins produced by the liver misfold and accumulate in the heart, leading to impaired cardiac function. Without treatment, the disease can be fatal within five years of diagnosis. BridgeBio's drug, scientifically known as acoramidis, is designed to stabilize these proteins, thereby reducing cardiovascular death and hospitalizations related to the condition.

The approval of Attruby is based on the positive outcomes from the ATTRibute-CM Phase 3 trial, which demonstrated significant reductions in all-cause mortality and cardiovascular-related hospitalizations. The trial involved 632 participants and showed that Attruby could reduce the risk of cardiovascular events by 42% compared to placebo.

BridgeBio's entry into the market sets up a competitive landscape against Pfizer's tafamidis, marketed as Vyndaqel and Vyndamax, which has been the leading treatment since its approval in 2019. The pricing strategy for Attruby is set at $18,759 for a 28-day supply, which is competitive against Pfizer's annual cost of $225,000.

The approval also brings financial benefits to BridgeBio, including a $500 million payment under a royalty funding agreement. The company plans to expand its market reach by seeking regulatory approvals in Europe, Japan, and Brazil, with Bayer holding exclusive commercialization rights in Europe.

This development is a significant step forward for patients with ATTR-CM, offering a new hope for improved quality of life and survival rates. The competition between BridgeBio and Pfizer is expected to drive further advancements in treatment options for this challenging condition.