Cytokinetics presented additional data related to aficamten at the European Society of Cardiology Congress 2025.
The data highlights the improvements in cardiac structure and function compared to metoprolol.
There was a new analysis showing the incidence rate of atrial fibrillation with aficamten.
Superiority of Aficamten
Aficamten was shown to be superior to metoprolol in improving measures of diastolic function and reducing the likelihood of LVOT obstruction.
Safety Profile
The additional data presented continues to support the overall safety profile of aficamten, including real-world dosing strategies.
Regulatory Review
Aficamten is under regulatory review in the U.S., with an NDA being reviewed by the FDA with a target action date of December 26, 2025.
- The echocardiographic results from MAPLE-HCM reinforce the superiority of aficamten over metoprolol.
- Long-term data presented also indicate a minimal clinical impact of new-onset atrial fibrillation in patients with obstructive hypertrophic cardiomyopathy.
The data presented at the European Society of Cardiology Congress 2025 strengthen the evidence base supporting aficamten's efficacy and safety profile, paving the way for potential regulatory approval.