Human medicines European public assessment report (EPAR): Inaqovi, cedazuridine,decitabine, Date of authorisation: 15/09/2023, Revision: 4, Status: Authorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Inaqovi is a cancer medicine used in adults to treat newly diagnosed acute myeloid leukaemia (AML), a type of cancer affecting the white blood cells. It is used in patients who are not eligible for standard induction chemotherapy (initial treatment with cancer medicines). It can be used on its own or in combination with venetoclax, another cancer medicine.
Inaqovi contains two active substances, decitabine and cedazuridine.
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How is Inaqovi used?
The medicine can only be obtained with a prescription. Treatment with Inaqovi should be started and supervised by a doctor who has experience in the use of cancer treatments.
Inaqovi is available as tablets to be taken by mouth over cycles that last for 28 days. It is given once a day for the first 5 days of each cycle. The medicine is given for a minimum of 4 cycles or until the disease gets worse or side effects become unacceptable.
For more information about using Inaqovi, see the package leaflet or contact your doctor or pharmacist.
How does Inaqovi work?
The two active substances in Inaqovi, decitabine and cedazuridine, work in different ways. Decitabine is analogous (comparable) to cytidine, a fundamental component of the DNA (genetic material) in cells. In the body, it is incorporated into DNA where it blocks the activity of enzymes (proteins) called DNA methyltransferases (DNMTs). These enzymes promote the development and progression of cancer. By blocking DNMTs, decitabine reduces the growth of cancer cells and leads to their death.
Cedazuridine blocks the action of an enzyme that breaks down decitabine in the gut and liver. This prevents the premature breakdown of decitabine when it is given by mouth.
What benefits of Inaqovi have been shown in studies?
The benefits of Inaqovi were evaluated in an ongoing study involving 89 adults with newly diagnosed AML. Within the study patients were divided into two groups. For the first cycle of treatment, one group was given Inaqovi once daily for five days while the second group was given decitabine by infusion (drip) into a vein once daily for five days. For the second cycle, the treatments were reversed (i.e. the group given Inaqovi for the first cycle was given decitabine by infusion and vice versa). For the third and subsequent cycles, all patients were given Inaqovi.
Results showed that Inaqovi achieved the same levels of decitabine in the body as those observed when decitabine was given by infusion. In addition, results showed that 21% (19 out of 87) of patients achieved a complete response (no detectable sign of cancer) . On average, patients achieved a complete response three months after starting treatment. Complete responses to Inaqovi lasted for an average of approximately six months.
Data from an additional study showed that decitabine given as Inaqovi, taken in combination with venetoclax, behaves in the same way in the body as other medicines containing decitabine given by infusion and in combination with venetoclax. The combination of Inaqovi and venetoclax is therefore expected to have similar effectiveness as that of decitabine by infusion and venetoclax.
In addition, the study evaluated the effectiveness of Inaqovi in combination with venetoclax in 101 people with newly diagnosed AML. The study did not compare the combination with another medicine. After about 11 months on average, approximately 47% of people (47 out of 101) had a complete response to treatment. Studies carried out with Inaqovi are described in more detail in the medicine’s assessment reports.
What are the side effects and restrictions with Inaqovi?
For the full list of side effects and restrictions with Inaqovi, see the package leaflet.
The most common side effects with Inaqovi (which may affect more than 1 in 5 people) include thrombocytopenia (low levels of blood platelets, components which help the blood to clot) and febrile neutropenia (low levels of white blood cells with fever).
Some side effects can be serious. The most frequent (which may affect more than 1 in 5 people) include pneumonia (infection of the lungs), sepsis (when bacteria and their toxins circulate in the blood leading to organ damage) and febrile neutropenia.
Inaqovi must not be used in women who are breast-feeding.
Why is Inaqovi authorised in the EU?
Decitabine given as Inaqovi, with or without venetoclax, was shown to behave in the same way in the body as other medicines containing decitabine given by infusion. The medicine is therefore expected to have comparable effectiveness in the treatment of adults with AML. Patients not suitable for induction therapy are often treated with medicines given by injection or infusion in combination with venetoclax tablets. As Inaqovi is a tablet given by mouth, it reduces the burden associated with receiving injections or infusions for both patients and their caregivers. The side effects of Inaqovi are similar to those of other medicines containing decitabine given by infusion. Although the safety data for Inaqovi are limited, extensive data are available on decitabine given by infusion, and no new side effects associated with either cedazuridine or decitabine given by mouth were identified.
The European Medicines Agency decided that Inaqovi’s benefits are greater than its risks and it can be authorised for use in the EU.
What measures are being taken to ensure the safe and effective use of Inaqovi?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Inaqovi have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Inaqovi are continuously monitored. Suspected side effects reported with Inaqovi are carefully evaluated and any necessary action taken to protect patients.
Other information about Inaqovi
Inaqovi received a marketing authorisation valid throughout the EU on 15 September 2023.
Inaqovi : EPAR - Medicine overview
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EMADOC-1829012207-50549
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Inaqovi : EPAR - Risk management plan
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Product information
Inaqovi : EPAR - Product information
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Latest procedure affecting product information:
VR/0000304730
19/06/2026
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).
Inaqovi : EPAR - All authorised presentations
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Product details
Name of medicine
Inaqovi
Active substance
- cedazuridine
- decitabine
International non-proprietary name (INN) or common name
- cedazuridine
- decitabine
Therapeutic area (MeSH)
Leukemia, Myeloid
Anatomical therapeutic chemical (ATC) code
L01BC58
Pharmacotherapeutic group
Antineoplastic agents
Therapeutic indication
Inaqovi is indicated as monotherapy for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for standard induction chemotherapy.
Inaqovi in combination with venetoclax is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for standard induction chemotherapy.
Authorisation details
EMA product number
EMEA/H/C/005823
Additional monitoring
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.
Marketing authorisation holder
Otsuka Pharmaceutical Netherlands B.V.
Herikerbergweg 292 1101 CT Amsterdam Netherlands
Opinion adopted
20/07/2023
Marketing authorisation issued
15/09/2023
Revision
4
Assessment history
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Changes since initial authorisation of medicine
Inaqovi : EPAR - Procedural steps taken and scientific information after the authorisation
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27/01/2025
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Inaqovi : EPAR - Procedural steps taken and scientific information after the authorisation (archive)
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27/01/2025
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Inaqovi-VR-0000304730 : EPAR - Assessment report - Variation
Adopted
Reference Number:
EMADOC-1700519818-3144762
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25/06/2026
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CHMP post-authorisation summary of positive opinion for Inaqovi (VR-0000304730)
Adopted
Reference Number:
EMADOC-1700519818-3050557
English (EN) (146.16 KB - PDF)
First published:
24/04/2026
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Initial marketing authorisation documents
Inaqovi : Orphan designation withdrawal assessment report
Reference Number:
EMA/OD/0000141337
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30/11/2023
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Inaqovi : EPAR - Public assessment report
Adopted
Reference Number:
EMA/CHMP/402324/2023
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First published:
30/11/2023
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CHMP summary of positive opinion for Inaqovi
Adopted
Reference Number:
EMA/324132/2023
English (EN) (132.03 KB - PDF)
First published:
21/07/2023
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News on Inaqovi
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 April 2026
24/04/2026
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 November 2024
15/11/2024
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 July 2023
21/07/2023
More information on Inaqovi
This product is no longer an orphan medicine. It was originally designated an orphan medicine on 10 December 2021. Cedazuridine, decitabine was withdrawn from the Union Register of orphan medicinal products by the European Commission in July 2023 upon request of the marketing authorisation holder at the time of the granting of a marketing authorisation.
More information on Inaqovi
- EMA/PE/0000182217 - paediatric investigation plan
- Inaqovi - withdrawal of application for variation to marketing authorisation
This page was last updated on
25/06/2026
Summary
Inaqovi is a cancer medicine used in adults to treat newly diagnosed acute myeloid leukaemia (AML), a type of cancer affecting the white blood cells. It is used in patients who are not eligible for standard induction chemotherapy (initial treatment with cancer medicines). It can be used on its own or in combination with venetoclax, another cancer medicine. Inaqovi contains two active substances, decitabine and cedazuridine.