Deltyba

delamanid

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This is a summary of the European public assessment report (EPAR) for Deltyba. 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 Deltyba.

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

What is Deltyba and what is it used for?

Deltyba is a tuberculosis medicine that contains the active substance delamanid. Tuberculosis is an infection caused by the bacterium Mycobacterium tuberculosis (M. tuberculosis). Deltyba is used in adults with tuberculosis that is affecting the lung and that is multi-drug resistant (resistant to at least isoniazid and rifampicin, two standard anti-tuberculosis medicines). It is used together with other standard medicines and when other combinations without this medicine cannot be used either because the disease is resistant to them or because of their side effects.

Because the number of patients with tuberculosis is low in the EU, the disease is considered ‘rare’, and Deltyba was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 1 February 2008.

How is Deltyba used?

Deltyba can only be obtained with a prescription and treatment should be started and monitored by a doctor who is experienced in the treatment of multi-drug resistant tuberculosis.

The medicine is available as tablets (50 mg) and the recommended dose is two tablets twice a day taken together with food. Deltyba is given for 6 months together with other standard medicines. Treatment with these standard medicines should continue as recommended by official guidelines after completion of Deltyba treatment. For further information, see the package leaflet.

How does Deltyba work?

The active substance in Deltyba, delamanid, is an antibiotic active against M. tuberculosis. Although the precise mode of action is unclear, delamanid is known to block the production of methoxy-mycolic and keto-mycolic acids, two essential components of the cell walls of M. tuberculosis, which will cause the bacteria to die.

What benefits of Deltyba have been shown in studies?

The effects of Deltyba have been looked at in one main study involving 481 adults with tuberculosis resistant to standard treatments. Patients in the study were given Deltyba or placebo (a dummy treatment) for 2 months in addition to their other treatments. The main measure of effectiveness was the proportion of patients who no longer had the bacteria in their sputum (phlegm). After 2 months of treatment more than 40% of the patients who were taking Deltyba no longer had the bacteria in their sputum compared with 30% of the patients who were taking placebo.

After the main study had finished, patients had the option to receive treatment with Deltyba for 6 months in an extension study. In addition, a majority of patients who entered the main study were followed up for up to 24 months afterwards. Looking at the results of these follow-up studies together, 2 years after starting treatment 75% of patients who received Deltyba for 6 months or more had no bacteria in their sputum compared with 55% of patients who received Deltyba for 2 months or less.

What are the risks associated with Deltyba?

The most common side effects with Deltyba (which may affect around a third of patients) are nausea, vomiting and dizziness. The most serious side effect is QT prolongation (an alteration of the electrical activity of the heart which can cause a life-threatening abnormality of heart rhythm). Other important side effects are anxiety, paraesthesia (unusual sensations like pins and needles) and tremor (shaking). For the full list of all side effects reported with Deltyba, see the package leaflet.

Deltyba must not be used in patients who have low levels of albumin (a blood protein). It must also not be used in patients who are taking certain other medicines that affect the way Deltyba is broken down in the body. For the full list of restrictions, see the package leaflet.

Why is Deltyba approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Deltyba’s benefits are greater than its risks and recommended that it be approved for use in the EU. The Committee considered that the benefits of Deltyba had been shown for patients with multi-drug resistant tuberculosis affecting the lung. Although the main study was of short duration and the follow-up studies had shortcomings, the CHMP took the view that the effects shown after the initial 2 months of treatment are likely to be sustained for the full treatment duration. The CHMP noted that an on-going clinical study will provide confirmation on the long-term effectiveness. In addition, the CHMP required that an additional study should be carried out to confirm that the current recommended dose is the most appropriate dose.

Regarding the safety of Deltyba, the safety profile was considered manageable and several measures were introduced to minimise the risks, including a study to confirm the long-term safety. Furthermore the Committee highlighted the medical need for new agents to treat multi-drug resistant tuberculosis.

Deltyba has been given ‘conditional approval’. This means that there is more evidence to come about the medicine, which the company is required to provide. Every year, the European Medicines Agency will review any new information that becomes available and this summary will be updated as necessary.

What information is still awaited for Deltyba?

Since Deltyba has been granted a conditional approval, the company that markets Deltyba will carry out further studies to confirm the long-term effectiveness and safety of Deltyba. A further study will also be carried out to confirm the most appropriate dose.

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

A risk management plan has been developed to ensure that Deltyba 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 Deltyba, including the appropriate precautions to be followed by healthcare professionals and patients.

In addition, the company that markets Deltyba will provide educational material for healthcare professionals, explaining how to use the medicine safely in order to avoid problems such as the development of resistance and side effects on the heart, as well as the risks in pregnancy or women who are breast-feeding.

Other information about Deltyba

The European Commission granted a marketing authorisation valid throughout the European Union for Deltyba on 28 April 2014.

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

Name Language First published Last updated
Deltyba : EPAR - Summary for the public BG = bălgarski 08/05/2014  
Deltyba : EPAR - Summary for the public ES = español 08/05/2014  
Deltyba : EPAR - Summary for the public CS = čeština 08/05/2014  
Deltyba : EPAR - Summary for the public DA = dansk 08/05/2014  
Deltyba : EPAR - Summary for the public DE = Deutsch 08/05/2014  
Deltyba : EPAR - Summary for the public ET = eesti keel 08/05/2014  
Deltyba : EPAR - Summary for the public EL = elliniká 08/05/2014  
Deltyba : EPAR - Summary for the public EN = English 08/05/2014  
Deltyba : EPAR - Summary for the public FR = français 08/05/2014  
Deltyba : EPAR - Summary for the public IT = italiano 08/05/2014  
Deltyba : EPAR - Summary for the public LV = latviešu valoda 08/05/2014  
Deltyba : EPAR - Summary for the public LT = lietuvių kalba 08/05/2014  
Deltyba : EPAR - Summary for the public HU = magyar 08/05/2014  
Deltyba : EPAR - Summary for the public MT = Malti 08/05/2014  
Deltyba : EPAR - Summary for the public NL = Nederlands 08/05/2014  
Deltyba : EPAR - Summary for the public PL = polski 08/05/2014  
Deltyba : EPAR - Summary for the public PT = português 08/05/2014  
Deltyba : EPAR - Summary for the public RO = română 08/05/2014  
Deltyba : EPAR - Summary for the public SK = slovenčina 08/05/2014  
Deltyba : EPAR - Summary for the public SL = slovenščina 08/05/2014  
Deltyba : EPAR - Summary for the public FI = suomi 08/05/2014  
Deltyba : EPAR - Summary for the public SV = svenska 08/05/2014  
Deltyba : EPAR - Summary for the public HR = Hrvatski 08/05/2014  

This EPAR was last updated on 18/04/2016 .

Authorisation details

Product details

Product details for Deltyba
NameDeltyba
Agency product numberEMEA/H/C/002552
Active substance

delamanid

International non-proprietary name (INN) or common name

delamanid

Therapeutic area Tuberculosis, Multidrug-Resistant
Anatomical therapeutic chemical (ATC) code J04AK06
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.

Conditional Approval

Sometimes, the CHMP recommends that a medicine be given ‘conditional approval’. This happens when the Committee has based its positive opinion on data which, while not yet comprehensive, indicate that the medicine’s benefits outweigh its risks.

The company is given obligations to fulfil, such as the performance of further studies. The approval is renewed on a yearly basis until all obligations have been fulfilled, and is then converted from a conditional approval into a normal approval. Conditional approvals can only be granted for medicines that satisfy an ‘unmet medical need’, meaning the medicine is intended to be used for a disease or condition for which no treatment is readily available, and it is therefore important that patients have early access to the medicine concerned.

Publication details

Publication details for Deltyba
Marketing-authorisation holder

Otsuka Novel Products GmbH

Revision4
Date of issue of marketing authorisation valid throughout the European Union28/04/2014

Contact address:

Otsuka Novel Products GmbH
Erika-Mann-Strasse 21
D-80636 München 
Germany

Product information

Product information

04/03/2016  Deltyba -EMEA/H/C/002552 -N/0012

Name Language First published Last updated
Deltyba : EPAR - Product Information HR = Hrvatski 08/05/2014 18/04/2016
Deltyba : EPAR - Product Information HR = Hrvatski 08/05/2014 18/04/2016
Deltyba : EPAR - Product Information HR = Hrvatski 08/05/2014 18/04/2016
Deltyba : EPAR - Product Information HR = Hrvatski 08/05/2014 18/04/2016
Deltyba : EPAR - Product Information HR = Hrvatski 08/05/2014 18/04/2016
Deltyba : EPAR - Product Information HR = Hrvatski 08/05/2014 18/04/2016
Deltyba : EPAR - Product Information HR = Hrvatski 08/05/2014 18/04/2016
Deltyba : EPAR - Product Information HR = Hrvatski 08/05/2014 18/04/2016
Deltyba : EPAR - Product Information HR = Hrvatski 08/05/2014 18/04/2016
Deltyba : EPAR - Product Information HR = Hrvatski 08/05/2014 18/04/2016
Deltyba : EPAR - Product Information HR = Hrvatski 08/05/2014 18/04/2016
Deltyba : EPAR - Product Information HR = Hrvatski 08/05/2014 18/04/2016
Deltyba : EPAR - Product Information HR = Hrvatski 08/05/2014 18/04/2016
Deltyba : EPAR - Product Information HR = Hrvatski 08/05/2014 18/04/2016
Deltyba : EPAR - Product Information HR = Hrvatski 08/05/2014 18/04/2016
Deltyba : EPAR - Product Information HR = Hrvatski 08/05/2014 18/04/2016
Deltyba : EPAR - Product Information HR = Hrvatski 08/05/2014 18/04/2016
Deltyba : EPAR - Product Information HR = Hrvatski 08/05/2014 18/04/2016
Deltyba : EPAR - Product Information HR = Hrvatski 08/05/2014 18/04/2016
Deltyba : EPAR - Product Information HR = Hrvatski 08/05/2014 18/04/2016
Deltyba : EPAR - Product Information HR = Hrvatski 08/05/2014 18/04/2016
Deltyba : EPAR - Product Information HR = Hrvatski 08/05/2014 18/04/2016
Deltyba : EPAR - Product Information HR = Hrvatski 08/05/2014 18/04/2016
Deltyba : EPAR - Product Information HR = Hrvatski 08/05/2014 18/04/2016
Deltyba : EPAR - Product Information HR = Hrvatski 08/05/2014 18/04/2016

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
Deltyba : EPAR - All Authorised presentations HR = Hrvatski 08/05/2014 08/10/2014
Deltyba : EPAR - All Authorised presentations HR = Hrvatski 08/05/2014 08/10/2014
Deltyba : EPAR - All Authorised presentations HR = Hrvatski 08/05/2014 08/10/2014
Deltyba : EPAR - All Authorised presentations HR = Hrvatski 08/05/2014 08/10/2014
Deltyba : EPAR - All Authorised presentations HR = Hrvatski 08/05/2014 08/10/2014
Deltyba : EPAR - All Authorised presentations HR = Hrvatski 08/05/2014 08/10/2014
Deltyba : EPAR - All Authorised presentations HR = Hrvatski 08/05/2014 08/10/2014
Deltyba : EPAR - All Authorised presentations HR = Hrvatski 08/05/2014 08/10/2014
Deltyba : EPAR - All Authorised presentations HR = Hrvatski 08/05/2014 08/10/2014
Deltyba : EPAR - All Authorised presentations HR = Hrvatski 08/05/2014 08/10/2014
Deltyba : EPAR - All Authorised presentations HR = Hrvatski 08/05/2014 08/10/2014
Deltyba : EPAR - All Authorised presentations HR = Hrvatski 08/05/2014 08/10/2014
Deltyba : EPAR - All Authorised presentations HR = Hrvatski 08/05/2014 08/10/2014
Deltyba : EPAR - All Authorised presentations HR = Hrvatski 08/05/2014 08/10/2014
Deltyba : EPAR - All Authorised presentations HR = Hrvatski 08/05/2014 08/10/2014
Deltyba : EPAR - All Authorised presentations HR = Hrvatski 08/05/2014 08/10/2014
Deltyba : EPAR - All Authorised presentations HR = Hrvatski 08/05/2014 08/10/2014
Deltyba : EPAR - All Authorised presentations HR = Hrvatski 08/05/2014 08/10/2014
Deltyba : EPAR - All Authorised presentations HR = Hrvatski 08/05/2014 08/10/2014
Deltyba : EPAR - All Authorised presentations HR = Hrvatski 08/05/2014 08/10/2014
Deltyba : EPAR - All Authorised presentations HR = Hrvatski 08/05/2014 08/10/2014
Deltyba : EPAR - All Authorised presentations HR = Hrvatski 08/05/2014 08/10/2014
Deltyba : EPAR - All Authorised presentations HR = Hrvatski 08/05/2014 08/10/2014
Deltyba : EPAR - All Authorised presentations HR = Hrvatski 08/05/2014 08/10/2014
Deltyba : EPAR - All Authorised presentations HR = Hrvatski 08/05/2014 08/10/2014

Pharmacotherapeutic group

Antimycobacterials

Therapeutic indication

Deltyba is indicated for use as part of an appropriate combination regimen for pulmonary multi-drug resistant tuberculosis (MDR-TB) in adult patients when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability.

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Deltyba : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 25/07/2014 18/04/2016

Initial marketing-authorisation documents

Name Language First published Last updated
Deltyba : EPAR - Public assessment report HR = Hrvatski 08/05/2014  
CHMP summary of positive opinion for Deltyba HR = Hrvatski 22/11/2013  
Questions and answers on refusal of the marketing authorisation for Delamanid HR = Hrvatski 26/07/2013