Akeega
Authorised
This medicine is authorised for use in the European Union
niraparib / abiraterone acetate
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Akeega is a cancer medicine for treating adult men with prostate cancer who have genetic mutations known as BRCA 1/2 mutations. It can be used:
when the cancer is metastatic (has spread to other parts of the body) and castration-resistant (worsens despite treatment to lower production of testosterone or after surgical removal of the testes); it is used when medical or surgical treatment to lower testosterone levels (castration) has not worked and when chemotherapy cannot be used;
together with hormone therapy (treatment to lower production of testosterone) when the cancer is metastatic (has spread to other parts of the body) and is hormone-sensitive (a cancer that depends on a hormone, such as testosterone, to grow).
Akeega is used in combination with prednisolone or another medicine, prednisone, which is converted into prednisolone.
Akeega contains two active substances: niraparib and abiraterone acetate.
Akeega is available as tablets to be taken by mouth on an empty stomach. The patient should take the medicine once a day for as long as they benefit from it or do not have unacceptable side effects.
The medicine can only be obtained with a prescription. For more information about using Akeega, see the package leaflet or contact your doctor or pharmacist.
Akeega contains two active substances: niraparib and abiraterone acetate. Niraparib blocks the action of enzymes called PARP-1 and PARP-2, which help to repair damaged DNA in cells when the cells divide to make new cells. The blocking of the PARP enzymes prevents cancer cells from repairing damaged DNA, and, as a result, the cancer cells die.
The other active substance, abiraterone acetate, stops the body from producing testosterone by blocking an enzyme called CYP17 found in the testes and elsewhere in the body. Because the cancer needs a supply of testosterone to survive and grow, abiraterone acetate helps slow the growth of the prostate cancer.
Two main studies in patients with castration-resistant prostate cancer looked at how effective Akeega was at slowing the worsening of the disease. The first study found that in 225 patients with BRCA 1/2 mutations, the time it took for scans to show the disease getting worse was around 17 months with Akeega, compared to 11 months in those treated with abiraterone acetate plus placebo (a dummy treatment). Patients in both groups also received prednisone.
The second main study in 696 patients with metastatic prostate cancer who received hormone therapy found that the time it took for scans to show the disease was getting worse was around 26 months in patients who had BRCA 1/2 mutations and who were taking abiraterone plus placebo; this time could not be calculated in patients who received Akeega as only a limited number of patients had a worsening of their disease by this time.
For the full list of side effects and restrictions with Akeega, see the package leaflet.
The most common side effects with Akeega (which may affect more than 1 in 10 people) include anaemia (low levels of red blood cells), high blood pressure, constipation, tiredness, nausea (feeling sick), thrombocytopenia (low levels of blood platelets), dyspnoea (difficulty breathing), back pain, reduced appetite, neutropenia (low levels of neutrophils, a type of white blood cell), leucopenia (low levels of white blood cells), muscle and joint pain, vomiting, low levels of potassium, dizziness, difficulty sleeping, abdominal (belly) pain, oedema (swelling, fluid retention), respiratory tract infections (nose, throat or lungs infection), decreased weight, headache, diarrhoea, hot flush, lymphopenia (low levels of lymphocytes, a type of white blood cells), cough, high blood glucose and creatinine (a breakdown product of muscle removed by the kidneys) levels and urinary tract infection.
Akeega must not be used in patients with severe liver problems and should not be administered in combination with Radium-223, a type of radiotherapy.
Akeega is not for use in women. As it may cause harm to the unborn baby, patients engaged in sexual activity with a woman who is pregnant or can become pregnant should use contraception.
A main study showed that Akeega was effective at slowing the worsening of castration-resistant prostate cancer that has spread to other parts of the body in patients with BRCA 1/2 mutations who cannot receive chemotherapy. Akeega was also shown to be effective in another main study when used together with hormone therapy in patients with metastatic prostate cancer with BRCA 1/2 mutations, a patient group with particularly high unmet medical need.Most of side effects of Akeega are those seen when the individual active substances are used alone. Although some side effects were serious, they were generally manageable. The European Medicines Agency therefore decided that the benefits of Akeega are greater than its risks and it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Akeega have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Akeega are continuously monitored. Suspected side effects reported with Akeega are carefully evaluated and any necessary action taken to protect patients.
Akeega received a marketing authorisation valid throughout the EU on 19 April 2023.
Product information
Latest procedure affecting product information:EMA/VR/0000282377
05/03/2026
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
- Akeega
- Active substance
- abiraterone acetate
- niraparib (tosilate monohydrate)
- International non-proprietary name (INN) or common name
- niraparib
- abiraterone acetate
- Therapeutic area (MeSH)
- Prostatic Neoplasms, Castration-Resistant
- Anatomical therapeutic chemical (ATC) code
- L01
Pharmacotherapeutic group
Antineoplastic agentsTherapeutic indication
Treatment of adult patients with prostate cancer.
News on Akeega
This page was last updated on