Ofev

nintedanib

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This is a summary of the European public assessment report (EPAR) for Ofev. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Ofev.

For practical information about using Ofev, patients should read the package leaflet or contact their doctor or pharmacist.

What is Ofev and what is it used for?

Ofev is a medicine used to treat adults with idiopathic pulmonary fibrosis (IPF). IPF is a long-term disease in which hard fibrous tissue continuously forms in the lungs, causing persistent cough and severe shortness of breath. ‘Idiopathic’ means that the cause of the disease is unknown.

Because the number of patients with IPF is low, the disease is considered ‘rare’, and Ofev was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 26 April 2013.

Ofev contains the active substance nintedanib.

How is Ofev used?

Ofev can only be obtained with a prescription, and treatment should be started by a doctor experienced in the diagnosis and treatment of IPF.

Ofev is available as capsules (100 and 150 mg). The recommended dose is 150 mg taken twice a day with food, approximately 12 hours apart. In patients who do not tolerate this dose, the dose should be reduced to 100 mg twice a day or treatment should be interrupted.

For further information, see the package leaflet.

How does Ofev work?

The active substance in Ofev, 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 seen in IPF. By blocking these enzymes, nintedanib helps to reduce the formation of fibrous tissue in the lungs, thereby helping to prevent the symptoms of IPF from getting worse.

What benefits of Ofev have been shown in studies?

Ofev has been compared with placebo (a dummy treatment) in two main studies involving a total of 1,066 patients with IPF. In both studies, the main measure of effectiveness was the decline in the functioning of the patients’ lungs over the course of 1 year of treatment, measured by their forced vital capacity (FVC). FVC is the maximum amount of air the patient can breathe out forcefully after taking in a deep breath and this decreases as the condition gets worse.

In both studies, patients taking Ofev had a smaller decline in FVC than patients taking placebo, meaning that Ofev slowed down the worsening of the condition. The average FVC of patients before treatment was between 2600 and 2700 millilitre (ml). In the first study, the average decrease in FVC over 1 year was 115 ml in patients taking Ofev compared with a decrease of 240 ml in patients taking placebo. In the second study, the average decrease was 114 ml for Ofev compared with 207 ml for placebo. A further analysis of the results of the 2 main studies, which took into account that some patients stopped treatment, confirmed the benefits of Ofev over placebo, although the difference in FVC between the two was less pronounced.

What are the risks associated with Ofev?

The most common side effects with Ofev (which may affect more than 1 in 10 people) are diarrhoea, nausea (feeling sick), abdominal pain (stomach ache) and raised levels of liver enzymes in the blood (a sign of liver problems); vomiting, decreased appetite and weight loss are also common. For the full list of all side effects reported with Ofev, see the package leaflet.

Ofev must not be used in patients who are hypersensitive (allergic) to nintedanib, peanut or soya, or any of the other ingredients.

Why is Ofev approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Ofev’s benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP considered that Ofev has been shown to be effective at slowing down the worsening of lung function in patients with IPF. Regarding safety, the side effects associated with Ofev were considered manageable with dose interruptions or reductions.

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

A risk management plan has been developed to ensure that Ofev is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Ofev, including the appropriate precautions to be followed by healthcare professionals and patients.

Further information can be found in the summary of the risk management plan.

Other information about Ofev

The European Commission granted a marketing authorisation valid throughout the European Union for Ofev on 15 January 2015.

For more information about treatment with Ofev, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Ofev : EPAR - Summary for the public BG = bălgarski 2015-02-13  
Ofev : EPAR - Summary for the public ES = español 2015-02-13  
Ofev : EPAR - Summary for the public CS = čeština 2015-02-13  
Ofev : EPAR - Summary for the public DA = dansk 2015-02-13  
Ofev : EPAR - Summary for the public DE = Deutsch 2015-02-13  
Ofev : EPAR - Summary for the public ET = eesti keel 2015-02-13  
Ofev : EPAR - Summary for the public EL = elliniká 2015-02-13  
Ofev : EPAR - Summary for the public EN = English 2015-02-13  
Ofev : EPAR - Summary for the public FR = français 2015-02-13  
Ofev : EPAR - Summary for the public IT = italiano 2015-02-13  
Ofev : EPAR - Summary for the public LV = latviešu valoda 2015-02-13  
Ofev : EPAR - Summary for the public LT = lietuvių kalba 2015-02-13  
Ofev : EPAR - Summary for the public HU = magyar 2015-02-13  
Ofev : EPAR - Summary for the public MT = Malti 2015-02-13  
Ofev : EPAR - Summary for the public NL = Nederlands 2015-02-13  
Ofev : EPAR - Summary for the public PL = polski 2015-02-13  
Ofev : EPAR - Summary for the public PT = português 2015-02-13  
Ofev : EPAR - Summary for the public RO = română 2015-02-13  
Ofev : EPAR - Summary for the public SK = slovenčina 2015-02-13  
Ofev : EPAR - Summary for the public SL = slovenščina 2015-02-13  
Ofev : EPAR - Summary for the public FI = suomi 2015-02-13  
Ofev : EPAR - Summary for the public SV = svenska 2015-02-13  
Ofev : EPAR - Summary for the public HR = Hrvatski 2015-02-13  
Name Language First published Last updated
Ofev : EPAR - Risk-management-plan summary (English only) 2015-02-13  

This EPAR was last updated on 20/10/2016 .

Authorisation details

Product details

Product details for Ofev
NameOfev
Agency product numberEMEA/H/C/003821
Active substance

nintedanib

International non-proprietary name (INN) or common name

nintedanib

Therapeutic area Idiopathic Pulmonary Fibrosis
Anatomical therapeutic chemical (ATC) code L01XE
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Treatment of rare diseases

This medicine has an "orphan designation" which means that it is used to treat life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in the European Union, or are medicines which, for economic reasons, would be unlikely to be developed without incentives.

Publication details

Publication details for Ofev
Marketing-authorisation holder

Boehringer Ingelheim International GmbH

Revision3
Date of issue of marketing authorisation valid throughout the European Union15/01/2015

Contact address:

Binger Strasse 173
55216 Ingelheim am Rhein
Germany

Product information

Product information

02/09/2016  Ofev -EMEA/H/C/003821 -II/0006

Name Language First published Last updated
Ofev : EPAR - Product Information EN = English 2015-02-13 2016-10-20
Ofev : EPAR - Product Information EN = English 2015-02-13 2016-10-20
Ofev : EPAR - Product Information EN = English 2015-02-13 2016-10-20
Ofev : EPAR - Product Information EN = English 2015-02-13 2016-10-20
Ofev : EPAR - Product Information EN = English 2015-02-13 2016-10-20
Ofev : EPAR - Product Information EN = English 2015-02-13 2016-10-20
Ofev : EPAR - Product Information EN = English 2015-02-13 2016-10-20
Ofev : EPAR - Product Information EN = English 2015-02-13 2016-10-20
Ofev : EPAR - Product Information EN = English 2015-02-13 2016-10-20
Ofev : EPAR - Product Information EN = English 2015-02-13 2016-10-20
Ofev : EPAR - Product Information EN = English 2015-02-13 2016-10-20
Ofev : EPAR - Product Information EN = English 2015-02-13 2016-10-20
Ofev : EPAR - Product Information EN = English 2015-02-13 2016-10-20
Ofev : EPAR - Product Information EN = English 2015-02-13 2016-10-20
Ofev : EPAR - Product Information EN = English 2015-02-13 2016-10-20
Ofev : EPAR - Product Information EN = English 2015-02-13 2016-10-20
Ofev : EPAR - Product Information EN = English 2015-02-13 2016-10-20
Ofev : EPAR - Product Information EN = English 2015-02-13 2016-10-20
Ofev : EPAR - Product Information EN = English 2015-02-13 2016-10-20
Ofev : EPAR - Product Information EN = English 2015-02-13 2016-10-20
Ofev : EPAR - Product Information EN = English 2015-02-13 2016-10-20
Ofev : EPAR - Product Information EN = English 2015-02-13 2016-10-20
Ofev : EPAR - Product Information EN = English 2015-02-13 2016-10-20
Ofev : EPAR - Product Information EN = English 2015-02-13 2016-10-20
Ofev : EPAR - Product Information EN = English 2015-02-13 2016-10-20

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Ofev : EPAR - All Authorised presentations EN = English 2015-02-13  
Ofev : EPAR - All Authorised presentations EN = English 2015-02-13  
Ofev : EPAR - All Authorised presentations EN = English 2015-02-13  
Ofev : EPAR - All Authorised presentations EN = English 2015-02-13  
Ofev : EPAR - All Authorised presentations EN = English 2015-02-13  
Ofev : EPAR - All Authorised presentations EN = English 2015-02-13  
Ofev : EPAR - All Authorised presentations EN = English 2015-02-13  
Ofev : EPAR - All Authorised presentations EN = English 2015-02-13  
Ofev : EPAR - All Authorised presentations EN = English 2015-02-13  
Ofev : EPAR - All Authorised presentations EN = English 2015-02-13  
Ofev : EPAR - All Authorised presentations EN = English 2015-02-13  
Ofev : EPAR - All Authorised presentations EN = English 2015-02-13  
Ofev : EPAR - All Authorised presentations EN = English 2015-02-13  
Ofev : EPAR - All Authorised presentations EN = English 2015-02-13  
Ofev : EPAR - All Authorised presentations EN = English 2015-02-13  
Ofev : EPAR - All Authorised presentations EN = English 2015-02-13  
Ofev : EPAR - All Authorised presentations EN = English 2015-02-13  
Ofev : EPAR - All Authorised presentations EN = English 2015-02-13  
Ofev : EPAR - All Authorised presentations EN = English 2015-02-13  
Ofev : EPAR - All Authorised presentations EN = English 2015-02-13  
Ofev : EPAR - All Authorised presentations EN = English 2015-02-13  
Ofev : EPAR - All Authorised presentations EN = English 2015-02-13  
Ofev : EPAR - All Authorised presentations EN = English 2015-02-13  
Ofev : EPAR - All Authorised presentations EN = English 2015-02-13  
Ofev : EPAR - All Authorised presentations EN = English 2015-02-13  

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Ofev is indicated in adults for the treatment of Idiopathic Pulmonary Fibrosis (IPF).

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Ofev : EPAR - Public assessment report EN = English 2015-02-13  
CHMP summary of positive opinion for Ofev EN = English 2014-11-21