In a landmark decision, the U.S. Food and Drug Administration has granted approval for BridgeBio's revolutionary drug, Attruby, designed to treat transthyretin amyloid cardiomyopathy (ATTR-CM), a rare and fatal heart condition characterized by the accumulation of faulty transthyretin proteins in the heart. This approval marks a significant breakthrough in a market historically dominated by Pfizer's Vyndaqel.
ATTR-CM, a debilitating condition affecting over 120,000 adults in the United States, impairs the heart's ability to effectively pump blood, ultimately leading to organ failure if left untreated. BridgeBio's Attruby, priced at $18,759.12 for a 28-day supply, offers a viable alternative to Pfizer’s Vyndaqel, which commands a list price of $225,000 per year.
BridgeBio's application for Attruby was supported by compelling data from a comprehensive late-stage study involving 632 patients. The study demonstrated that Attruby substantially improved patient survival rates and reduced heart disease-related hospitalizations after 30 months of treatment. Notably, while Attruby did not achieve statistical significance in one secondary endpoint measuring overall mortality at 30 months, its primary efficacy in improving patient outcomes remains remarkable.
Unlike Pfizer's stabilizing treatment approach with tafamidis, Attruby works by stabilizing the faulty proteins, positioning itself as a compelling option for patients with ATTR-CM. The partnership between BridgeBio and Bayer for European distribution, alongside collaboration with AstraZeneca's Alexion for the Japanese market, underscores the global potential of Attruby.
Analysts anticipate that Attruby, despite facing initial challenges due to established competition, will amass global sales of $2.5 billion at its peak by 2035. Moreover, the introduction of Attruby provides patients with increased treatment options, heightens disease awareness, and potentially enhances diagnostic rates, ultimately benefiting the broader patient community.
As BridgeBio prepares for the launch of Attruby in the United States, the medical community eagerly anticipates the positive impact this breakthrough treatment will have on patients suffering from ATTR-CM.