Myqorzo
Authorised
This medicine is authorised for use in the European Union
aficamten
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Myqorzo is a medicine used to treat adults with obstructive hypertrophic cardiomyopathy (oHCM), a disease in which the muscle in the main pumping chamber of the heart becomes thickened or enlarged, which can block the flow of blood from the heart to the rest of the body. This can cause shortness of breath, chest pain, feeling faint and palpitations.
It is used in adults who have symptoms of the disease (class II or class III oHCM). The class reflects the seriousness of the disease: class II involves slight limitation of physical activity and class III involves marked limitation of physical activity.
Myqorzo contains the active substance aficamten.
Myqorzo can only be obtained with a prescription and treatment should be started and supervised by a doctor with experience in treating cardiomyopathy.
The medicine is available as tablets to be taken by mouth once a day. Before starting treatment, the doctor will carry out an echocardiogram to assess the patient’s heart function. This is a diagnostic test where an image of the heart is obtained using an ultrasound. At the start of treatment, the dose will be adjusted based on the results of echocardiograms carried out every 2 to 8 weeks, until the most suitable dose is found. Once patients are on a stable dose of Myqorzo, these echocardiograms will be carried out every 3 to 6 months.
For more information about using Myqorzo, see the package leaflet or contact your doctor or pharmacist.
In people with obstructive hypertrophic cardiomyopathy, the heart muscle contracts forcefully and becomes abnormally thick. This can narrow the space through which the blood leaves the heart and reduce blood flow.
The active substance in Myqorzo, aficamten, partly blocks heart myosin, a protein that drives heart contraction. By limiting excessive contraction, the medicine allows the heart to relax more and improves the flow of blood out of the heart. This helps the heart pump blood more effectively and can relieve symptoms of obstructive hypertrophic cardiomyopathy.
A main study showed that Myqorzo improves the ability to exercise and quality of life of patients with class II or III oHCM and reduces the likelihood that they will need a major heart procedure called septal reduction therapy. This procedure reduces the size of the thickened heart muscle through surgery or by using a catheter (a thin tube passed through an artery into the heart).
The main study involved 282 adults who took either Myqorzo or placebo (a dummy treatment). Participants’ ability to exercise was measured with pVO₂max (the maximum volume of oxygen used during exercise). It helps understand how well the heart can pump blood to deliver oxygen to other parts of the body, with higher pVO2max indicating better physical capacity. After 24 weeks of treatment, people taking Myqorzo had an average increase in their pVO2max of 1.76 millilitres of oxygen per kilogram of body weight per minute, compared with 0.02 in people given placebo.
After 24 weeks of treatment, fewer patients treated with Myqorzo were considered to need septal reduction therapy, with about 13% (4 out of 32) of patients taking Myqorzo considered, compared with 48% (14 out of 29) of patients taking placebo.
Quality of life was measured using the KCCQ-CCS questionnaire that evaluates how heart disease affects a person’s symptoms and daily physical activities, with higher scores meaning fewer symptoms and better physical function. After 24 weeks of treatment, about 49% of patients treated with Myqorzo reported an increase of at least 10 points, compared with 27% of patients on placebo. A 10-point increase is considered a meaningful improvement in symptoms and daily activities. Overall, quality-of-life scores improved on average by 11.6 points with Myqorzo, compared with 4.3 points with placebo.
For the full list of side effects and restrictions with Myqorzo, see the package leaflet.
The most common side effects with Myqorzo (which may affect up to 1 in 10 people) include dizziness, systolic dysfunction (a condition where the heart cannot pump with enough force), palpitations (a forceful heartbeat that may be rapid or irregular) and high blood pressure.
Myqorzo must not be used in people who are taking certain medicines that affect how Myqorzo is broken down in the body, such as adagrasib (a medicine used to treat certain cancers), more than a single dose of fluconazole (a medicine used to treat fungal infections), rifampicin (an antibiotic used to treat infections like tuberculosis) and St John’s wort (an herbal supplement used for depression).
A study showed that Myqorzo helps patients with class II or III obstructive hypertrophic cardiomyopathy exercise and improves their quality of life. Treatment with Myqorzo also reduced the likelihood that patients would need septal reduction therapy, a major heart procedure that carries significant risks. There are some uncertainties about how well Myqorzo works beyond 24 weeks of treatment, and the company will provide further data to confirm the long-term benefits of the medicine.
Myqorzo is generally well tolerated. There is some uncertainty about the long-term effects of Myqorzo on the heart, and further data are needed to confirm its long-term safety.
There are limited data on whether Myqorzo can cause harm to an unborn child or pass through breast milk to affect a child, but based on how the medicine works, harmful effects are possible. A warning and guidance have therefore been included in the product information.
The European Medicines Agency therefore decided that Myqorzo’s benefits are greater than its risks and it can be authorised for use in the EU.
The company that markets Myqorzo will provide an information pack for doctors and a patient card for patients. This information pack includes information on the risk of harm to an unborn child and the need to use effective birth control during treatment. They will also highlight the risk of heart failure (when the heart does not pump blood as well as it should), the need for regular heart checks and the importance of seeking medical attention immediately if symptoms such as shortness of breath, chest pain, tiredness, leg swelling or a serious infection occur. Patients are also advised to inform their prescribing doctor before starting, stopping or changing any other medicine.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Myqorzo have also been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Myqorzo are continuously monitored. Suspected side effects reported with Myqorzo are carefully evaluated and any necessary action taken to protect patients.
Myqorzo received a marketing authorisation valid throughout the EU on 12 February 2026.
Product information
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Myqorzo
- Active substance
- aficamten
- International non-proprietary name (INN) or common name
- aficamten
- Therapeutic area (MeSH)
- Cardiomyopathy, Hypertrophic
Therapeutic indication
Myqorzo is indicated for the treatment of symptomatic (New York Heart Association, NYHA, class II-III) obstructive hypertrophic cardiomyopathy (oHCM) in adult patients.
News on Myqorzo
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