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Beyonttra (Acoramidis) approved in Switzerland for patients with cardiac ATTR amyloidosis

December 18, 2025

On December 18, 2025, the Swiss regulatory authority Swissmedic approved the TTR stabilizer Acoramidis for the treatment of wild-type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM). The decision was based on the results of the Phase III ATTRibute-CM study (1).

Acoramidis belongs to the class of TTR stabilizers and prevents TTR from dissociating and forming amyloid deposits. Acoramidis is taken as film-coated tablets.

The pivotal ATTRibute-CM study enrolled 632 patients with ATTR-CM who received either Acoramidis or placebo for 30 months.

Key findings:

Fewer deaths and hospitalizations: In the overall group, there was a 42% reduced risk of death and hospitalizations due to heart problems compared to placebo. This effect was already visible after 3 months (2).
Participants in the Acoramidis group had a 50% lower risk of being hospitalized for heart problems than those in the placebo group (2).
Adverse events were similar in both groups, indicating that Acoramidis is well tolerated (1).
Longer survival: Continuation of therapy up to 42 months in an open-label extension study showed a significantly higher survival rate under Acoramidis compared to placebo and confirmed the good tolerability of Acoramidis (3).
Preservation of quality of life and functionality: Under therapy with Acoramidis, quality of life and functionality could be better maintained compared to placebo (1).

More detailed information about the ATTRibute-CM study has also been published in plain language in English (4).

References:

Primary publication of the ATTRibute study: Gillmore JD, et al. Efficacy and Safety of Acoramidis in Transthyretin Amyloid Cardiomyopathy. N Engl J Med. 2024 Jan 11;390(2):132-142. [Link]
ATTRibute-CM results on hospitalizations and mortality: Judge DP, et al. Efficacy of Acoramidis on All-Cause Mortality and Cardiovascular Hospitalization in Transthyretin Amyloid Cardiomyopathy. J Am Coll Cardiol. 2025 Mar 18;85(10):1003-1014. [Link]
Results of the open-label extension study: Judge DP, et al. Long-Term Efficacy and Safety of Acoramidis in ATTR-CM: Initial Report From the Open-Label Extension of the ATTRibute-CM Trial. Circulation. 2025 Mar 4;151(9):601-611 [Link]
The ATTRibute-CM study in plain language: Gillmore JD, et al. A plain language review of the ATTRibute-CM study: efficacy and safety of acoramidis in transthyretin amyloid cardiomyopathy. Future Cardiol 2025; Published online: 12 Dec 2025; DOI:10.1080/14796678.2025.2591426 [Link]

Vutrisiran approved in Switzerland for patients with cardiac ATTR amyloidosis

On October 16, 2025, the Swiss drug regulatory authority Swissmedic approved Vutrisiran as the first RNAi-based drug for the treatment of wild-type and hereditary transthyretin-mediated amyloidosis with cardiomyopathy (ATTR-CM) in adults in Switzerland.

The decision was based on the results of the Phase III HELIOS-B study:

M Fontana et al. Vutrisiran in Patients with Transthyretin Amyloidosis with Cardiomyopathy. N Engl J Med. 2024 Aug 30; 392:33-44

This novel therapy could benefit up to 100,000 patients in Europe, providing them with better quality of life and longer life expectancy.

With this decision, Vutrisiran is the first and only drug approved in Switzerland for both the polyneuropathic form (ATTRv-PN) and patients with cardiac involvement (ATTR-CM).

Vutrisiran is based on the principle of RNA interference. This specifically blocks genetic information - in this case, that responsible for the formation of the disease-causing protein transthyretin (TTR). A lower TTR level means: fewer harmful deposits, especially in the heart.

The drug is injected subcutaneously once every three months and can also be administered by patients themselves.

In the international Phase III HELIOS-B study, Vutrisiran was investigated in 655 patients with ATTR-CM.

The main results:

Fewer deaths and heart complications
In the study, there was a 28% reduced risk of death and severe cardiovascular events compared to placebo.
Longer survival
After about 3.5 years, the survival rate under Vutrisiran was significantly higher than under placebo.
Improved quality of life
Patients reported a more stable or even better life situation under therapy. This was confirmed by the KCCQ score (Kansas City Cardiomyopathy Questionnaire), a standardized instrument for measuring quality of life in heart failure. Under placebo, this value deteriorated significantly.

ATTRibute-CM study: Acoramidis in ATTR amyloidosis (wild-type and hereditary)

April 2024

In April 2024, the positive results of the phase 3 ATTRibute-CM study with Acoramidis were published in the New England Journal. Gillmore JD, et al. NEJM article

Acoramidis belongs to the class of TTR stabilizers and prevents TTR from dissociating and forming amyloid. The ATTRibute-CM study enrolled 632 patients who received either Acoramidis or placebo for 30 months. Results showed that Acoramidis led to better clinical outcomes compared with placebo, particularly for cardiac events and mortality. Adverse events were similar in both groups, indicating Acoramidis is generally well tolerated. Continued therapy up to 42 months in an open-label extension demonstrated increasing benefit and confirmed Acoramidis' tolerability (Judge DP, et al. Circulation open‑label extension) The ATTRibute-CM study formed the basis for approvals in the US and EU. Regulatory review in Switzerland is ongoing.

ATTRibute-CM Study Overview

A comprehensive overview of the efficacy and safety of Acoramidis in transthyretin amyloid cardiomyopathy.

(In English)

Download Overview (PDF)

CARES Study: Anselamimab in AL Amyloidosis

July 2025

On July 16, 2025, AstraZeneca presented interim results of the CARES Phase III program for the treatment of AL amyloidosis. In the overall group of patients with advanced disease (Mayo stages IIIa/IIIb), the antibody anselamimab could not significantly improve the primary endpoint – a combined assessment of overall survival and cardiovascular hospitalizations. However, in a predefined subgroup, it showed a clinically relevant extension of survival and fewer cardiac hospitalizations compared to placebo. The 406 study participants received anselamimab or placebo in addition to standard therapy; the treatment was well tolerated. Anselamimab is a novel anti-fibril antibody for the reduction of amyloid deposits; further analyses are ongoing, and the data will be presented at scientific conferences and submitted to regulatory authorities.

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