Basic Information
L01EX09
nintedanib
Antineoplastic agents
Therapeutic indication
Nintedanib Accord is indicated in adults for the treatment of idiopathic pulmonary fibrosis (IPF).
Nintedanib Accord is also indicated in adults for the treatment of other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype.
Nintedanib Accord is indicated in adults for the treatment of systemic sclerosis associated interstitial lung disease (SSc-ILD).
Overview Summary
Nintedanib Accord is a medicine used to treat adults with:
- idiopathic pulmonary fibrosis (IPF), a disease of unknown cause in which fibrous tissue forms in the lungs;
- systemic sclerosis associated interstitial lung disease, a disease in which the immune system (the body’s natural defences) is overactive, causing production of fibrous tissue and progressive scarring of the lungs;
- other chronic fibrosing interstitial lung diseases which are progressive.
Nintedanib Accord contains the active substance nintedanib and is a ‘generic medicine’. This means that Nintedanib Accord contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU. The reference medicine for Nintedanib Accord is Ofev. For more information on generic medicines, see the question-and-answer document here.
Active Substances (1)
nintedanib
Documents (9)
Nintedanib Accord : EPAR - Public assessment report
April 22, 2024
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
Nintedanib Accord : EPAR - All authorised presentations
April 22, 2024
AUTHORISED_PRESENTATIONS
Nintedanib Accord : EPAR - Procedural steps taken and scientific information after authorisation
June 20, 2024
CHANGES_SINCE_INITIAL_AUTHORISATION
CHMP summary of positive opinion for Nintedanib Accord
February 23, 2024
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
Nintedanib Accord : EPAR - Medicine overview
April 22, 2024
OVERVIEW_DOCUMENT
Nintedanib Accord : EPAR - Risk management plan
April 22, 2024
RISK_MANAGEMENT_PLAN_SUMMARY
Nintedanib Accord : EPAR - Public assessment report
April 22, 2024
CHANGES_SINCE_INITIAL_AUTHORISATION
CHMP summary of positive opinion for Nintedanib Accord
February 23, 2024
CHANGES_SINCE_INITIAL_AUTHORISATION
Nintedanib Accord : EPAR - Product information
April 22, 2024
DRUG_PRODUCT_INFORMATION
Overview Q&A (7)
Question
Why is Nintedanib Accord authorised in the EU?
Answer
The European Medicines Agency concluded that, in accordance with EU requirements, Nintedanib Accord has been shown to have comparable quality and to be bioequivalent to Ofev. Therefore, the Agency’s view was that, as for Ofev, the benefits of Nintedanib Accord outweigh the identified risks and it can be authorised for use in the EU.
Question
How is Nintedanib Accord used?
Answer
Nintedanib Accord can only be obtained with a prescription and treatment should be started by a doctor experienced in the diagnosis and treatment of the diseases it is used for.
It is available as capsules to be taken twice a day with food, approximately 12 hours apart.
For more information about using Nintedanib Accord, see the package leaflet or contact your doctor or pharmacist.
Question
How does Nintedanib Accord work?
Answer
The active substance in Nintedanib Accord, nintedanib, blocks the activity of some enzymes known as tyrosine kinases. These enzymes are present in certain receptors (such as VEGF, FGF and PDGF receptors) in cells in the lungs, where they activate several processes involved in the generation of fibrous tissue. By blocking these enzymes, nintedanib helps to reduce the formation of fibrous tissue in the lungs, thereby helping to prevent the symptoms of the disease from getting worse.
Question
How has Nintedanib Accord been studied?
Answer
Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Ofev, and do not need to be repeated for Nintedanib Accord.
As for every medicine, the company provided studies on the quality of Nintedanib Accord. The company also carried out a study that showed that it is ‘bioequivalent’ to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.
Question
What are the benefits and risks of Nintedanib Accord?
Answer
Because Nintedanib Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.
Question
What measures are being taken to ensure the safe and effective use of Nintedanib Accord?
Answer
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Nintedanib Accord have been included in the summary of product characteristics and the package leaflet.
Any additional measures in place for Ofev also apply to Nintedanib Accord where appropriate.
As for all medicines, data on the use of Nintedanib Accord are continuously monitored. Suspected side effects reported with Nintedanib Accord are carefully evaluated and any necessary action taken to protect patients.
Question
Other information about Nintedanib Accord
Answer
Nintedanib Accord received a marketing authorisation valid throughout the EU on 19 April 2024.