Nintedanib Accord

Authorised

This medicine is authorised for use in the European Union

nintedanib

Overview

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.

How is Nintedanib Accord used?

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.

How does Nintedanib Accord work?

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.

How has Nintedanib Accord been studied?

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.

What are the benefits and risks of Nintedanib Accord?

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.

Why is Nintedanib Accord authorised in the EU?

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.

What measures are being taken to ensure the safe and effective use of Nintedanib Accord?

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.

Other information about Nintedanib Accord

Nintedanib Accord received a marketing authorisation valid throughout the EU on 19 April 2024.

Nintedanib Accord : EPAR - Medicine overview

Reference Number: EMA/95127/2024

Nintedanib Accord : EPAR - Risk management plan

Product information

Nintedanib Accord : EPAR - 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).

Nintedanib Accord : EPAR - All authorised presentations

Product details

• Name of medicine:
  Nintedanib Accord
• Active substance:
  nintedanib
• International non-proprietary name (INN) or common name:
  nintedanib
• Therapeutic area (MeSH):
  • Idiopathic Pulmonary Fibrosis
  • Lung Diseases, Interstitial
  • Scleroderma, Systemic
• Anatomical therapeutic chemical (ATC) code:
  L01EX09

Pharmacotherapeutic group

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).

Authorisation details

• EMA product number:
  EMEA/H/C/006179
• Generic:

  This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

• Marketing authorisation holder:
  Accord Healthcare S.L.U.

  Edificio Este Planta 6a; World Trade Center; Moll De Barcelona S/n; 08039 Barcelona; SPAIN

• Opinion adopted:
  22/02/2024
• Opinion status:
  Positive
• Marketing authorisation issued:
  19/04/2024

Assessment history

Initial marketing authorisation documents

Nintedanib Accord : EPAR - Public assessment report

AdoptedReference Number: EMA/108684/2024

CHMP summary of positive opinion for Nintedanib Accord

AdoptedReference Number: EMA/CHMP/34939/2024