Acoramidis Advances with Positive CHMP Opinion for ATTR-CM

Acoramidis Receives Positive Opinion for ATTR-CM Treatment

The Committee for Medicinal Products for Human Use (CHMP) has issued a favorable opinion recommending the approval of acoramidis in the European Union (EU). This decision is anchored on the encouraging findings from the Phase 3 ATTRibute-CM study. Typically, the European Commission aligns its final approval decision with the CHMP's recommendation. Hence, a positive outcome is anticipated within the coming months.

Acoramidis, a Novel Treatment

Acoramidis is a selectively targeted small molecule designed to stabilize transthyretin (TTR), demonstrating over 90% effectiveness. On its journey toward becoming a vital treatment for heart conditions, acoramidis gained approval from the U.S. Food and Drug Administration (FDA) as Attruby™. This marks a significant breakthrough, as Attruby™ is the first medication approved in the United States for patients with transthyretin amyloid cardiomyopathy (ATTR-CM) with clear efficacy claims aimed at reducing cardiovascular-related events.

Significant Results from ATTRibute-CM Study

The Phase 3 ATTRibute-CM study yielded rapid and notable benefits for patients using acoramidis. Within merely three months, significant differences in all-cause mortality and cardiovascular-related hospitalizations were observed when compared to the placebo group. By month 30, there was a remarkable 42% reduction in composite events related to all-cause mortality and recurrent cardiovascular hospitalizations.

Understanding ATTR-CM and Its Impact

ATTR-CM is a progressive and often fatal disease characterized by an infiltrative form of cardiomyopathy that can lead to heart failure. Existing literature has linked increased stability of TTR to reduced mortality risks, emphasizing the critical need for effective treatments such as acoramidis.

The Future of Acoramidis in Europe

Following the positive CHMP opinion, the expectation is that the European Commission will mirror this recommendation, paving the way for acoramidis to be launched in the European market in early 2025. BridgeBio Pharma, alongside Bayer, is committed to bringing this treatment to the patients who need it most.

Collaboration with Bayer

BridgeBio Pharma and Bayer announced their partnership in March 2024, enhancing the distribution framework for acoramidis. This collaboration combines Bayer's expertise in cardiovascular issues with BridgeBio's extensive understanding of genetic medicine, aiming to deliver critical therapies swiftly to patients in Europe.

About Attruby™ (acoramidis)

Attruby™ is recognized as a near-complete stabilizer for TTR. It’s pivotal in managing adult patients with ATTR-CM, significantly targeting both cardiovascular deaths and hospitalizations. The treatment was generally well-received, with most side effects being mild and easily manageable.

Innovative Pursuits of BridgeBio

Founded in 2015, BridgeBio operates with an innovative approach to address genetic diseases and cancers with clear genetic drivers. The company’s commitment to rapid deployment of genetic medicine enables it to optimize patient outcomes effectively. Whether in early science or advanced clinical stages, BridgeBio focuses on delivering results that impact patient lives positively.

Frequently Asked Questions

What is acoramidis recommended for?

Acoramidis is recommended for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM) in adult patients.

What were the results of the ATTRibute-CM study?

The ATTRibute-CM study showed significant reductions in cardiovascular-related hospitalizations and mortality, marking rapid improvements in patient outcomes.

Who approved acoramidis in the United States?

The U.S. Food and Drug Administration (FDA) approved acoramidis as Attruby™, the first of its kind for ATTR-CM treatment in the U.S.

What is the timeline for acoramidis approval in Europe?

Acoramidis is expected to receive final approval from the European Commission, following the positive opinion from CHMP, with a probable launch in early 2025.

How does BridgeBio support patients?

BridgeBio offers extensive programs to help facilitate patient access to their therapies, ensuring support for those in need of innovative treatments.

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