Deltyba

delamanid

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An overview of Deltyba and why it is authorised in the EU

Deltyba is a medicine that is used in adults with tuberculosis affecting the lung and that is multi-drug resistant (resistant to at least isoniazid and rifampicin, the two standard tuberculosis medicines). It is used together with other tuberculosis medicines and only when other standard medicine cannot be used either because the disease is resistant to them or because of their side effects.

Deltyba contains the active substance delamanid.

Tuberculosis is rare in the EU, 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. It should be used according to official guidelines on treating multi-drug resistant tuberculosis.

The medicine is available as tablets (50 mg) and the recommended dose is two tablets twice a day taken with food. Deltyba is given for 6 months together with other tuberculosis medicines. Treatment with these medicines should continue after Deltyba treatment, as recommended by official guidelines. For more information about using Deltyba, see the package leaflet or contact a doctor or pharmacist.

How does Deltyba work?

Tuberculosis is an infection caused by the bacterium Mycobacterium tuberculosis (M. tuberculosis). The active substance in Deltyba, delamanid, is an antibiotic active against M. tuberculosis. Although the way it works 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 more than 1 patient in 10) are nausea, vomiting, headache, insomnia (sleeping problems), dizziness, tinnitus (ringing or buzzing in the ears), blood tests showing low potassium levels in the blood, gastritis (inflammation of the stomach lining), decreased appetite and weakness. For the full list of side effects of 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 authorised in the EU?

The European Medicines Agency decided that Deltyba’s benefits are greater than its risks and it can be authorised for use in the EU. The Agency 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 Agency considered that the effects shown after the initial 2 months of treatment are likely to be sustained for the full treatment duration. The Agency noted that an on-going clinical study will provide confirmation on the long-term effectiveness.

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 medical need for new agents to treat multi-drug resistant tuberculosis was highlighted.

Deltyba has been given ‘conditional authorisation’. 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 overview will be updated as necessary.

What information is still awaited for Deltyba?

Since Deltyba has been given conditional authorisation, the company that markets Deltyba will carry out further studies to confirm the long-term effectiveness and safety of Deltyba.

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

The company that markets Deltyba will provide educational material for healthcare professionals, explaining how to use the medicine safely 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.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Deltyba have also been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Deltyba are continuously monitored. Side effects reported with Deltyba are carefully evaluated and any necessary action taken to protect patients.

Other information about Deltyba

Deltyba received a marketing authorisation valid throughout the European Union on 28 April 2014.

Name Language First published Last updated
Deltyba : EPAR - Medicine overview BG = bălgarski 2014-05-08 2018-08-03
Deltyba : EPAR - Medicine overview ES = español 2014-05-08 2018-08-03
Deltyba : EPAR - Medicine overview CS = čeština 2014-05-08 2018-08-03
Deltyba : EPAR - Medicine overview DA = dansk 2014-05-08 2018-08-03
Deltyba : EPAR - Medicine overview DE = Deutsch 2014-05-08 2018-08-03
Deltyba : EPAR - Medicine overview ET = eesti keel 2014-05-08 2018-08-03
Deltyba : EPAR - Medicine overview EL = elliniká 2014-05-08 2018-08-03
Deltyba : EPAR - Medicine overview EN = English 2014-05-08 2018-08-03
Deltyba : EPAR - Medicine overview FR = français 2014-05-08 2018-08-03
Deltyba : EPAR - Medicine overview IT = italiano 2014-05-08 2018-08-03
Deltyba : EPAR - Medicine overview LV = latviešu valoda 2014-05-08 2018-08-03
Deltyba : EPAR - Medicine overview LT = lietuvių kalba 2014-05-08 2018-08-03
Deltyba : EPAR - Medicine overview HU = magyar 2014-05-08 2018-08-03
Deltyba : EPAR - Medicine overview MT = Malti 2014-05-08 2018-08-03
Deltyba : EPAR - Medicine overview NL = Nederlands 2014-05-08 2018-08-03
Deltyba : EPAR - Medicine overview PL = polski 2014-05-08 2018-08-03
Deltyba : EPAR - Medicine overview PT = português 2014-05-08 2018-08-03
Deltyba : EPAR - Medicine overview RO = română 2014-05-08 2018-08-03
Deltyba : EPAR - Medicine overview SK = slovenčina 2014-05-08 2018-08-03
Deltyba : EPAR - Medicine overview SL = slovenščina 2014-05-08 2018-08-03
Deltyba : EPAR - Medicine overview FI = suomi 2014-05-08 2018-08-03
Deltyba : EPAR - Medicine overview SV = svenska 2014-05-08 2018-08-03
Deltyba : EPAR - Medicine overview HR = Hrvatski 2014-05-08 2018-08-03

This EPAR was last updated on 03/08/2018 .

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

Revision9
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

11/06/2018  Deltyba -EMEA/H/C/002552 -IAIN/0031

Name Language First published Last updated
Deltyba : EPAR - Product Information HR = Hrvatski 2014-05-08 2018-08-03
Deltyba : EPAR - Product Information HR = Hrvatski 2014-05-08 2018-08-03
Deltyba : EPAR - Product Information HR = Hrvatski 2014-05-08 2018-08-03
Deltyba : EPAR - Product Information HR = Hrvatski 2014-05-08 2018-08-03
Deltyba : EPAR - Product Information HR = Hrvatski 2014-05-08 2018-08-03
Deltyba : EPAR - Product Information HR = Hrvatski 2014-05-08 2018-08-03
Deltyba : EPAR - Product Information HR = Hrvatski 2014-05-08 2018-08-03
Deltyba : EPAR - Product Information HR = Hrvatski 2014-05-08 2018-08-03
Deltyba : EPAR - Product Information HR = Hrvatski 2014-05-08 2018-08-03
Deltyba : EPAR - Product Information HR = Hrvatski 2014-05-08 2018-08-03
Deltyba : EPAR - Product Information HR = Hrvatski 2014-05-08 2018-08-03
Deltyba : EPAR - Product Information HR = Hrvatski 2014-05-08 2018-08-03
Deltyba : EPAR - Product Information HR = Hrvatski 2014-05-08 2018-08-03
Deltyba : EPAR - Product Information HR = Hrvatski 2014-05-08 2018-08-03
Deltyba : EPAR - Product Information HR = Hrvatski 2014-05-08 2018-08-03
Deltyba : EPAR - Product Information HR = Hrvatski 2014-05-08 2018-08-03
Deltyba : EPAR - Product Information HR = Hrvatski 2014-05-08 2018-08-03
Deltyba : EPAR - Product Information HR = Hrvatski 2014-05-08 2018-08-03
Deltyba : EPAR - Product Information HR = Hrvatski 2014-05-08 2018-08-03
Deltyba : EPAR - Product Information HR = Hrvatski 2014-05-08 2018-08-03
Deltyba : EPAR - Product Information HR = Hrvatski 2014-05-08 2018-08-03
Deltyba : EPAR - Product Information HR = Hrvatski 2014-05-08 2018-08-03
Deltyba : EPAR - Product Information HR = Hrvatski 2014-05-08 2018-08-03
Deltyba : EPAR - Product Information HR = Hrvatski 2014-05-08 2018-08-03
Deltyba : EPAR - Product Information HR = Hrvatski 2014-05-08 2018-08-03

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 2014-05-08 2017-11-13
Deltyba : EPAR - All Authorised presentations HR = Hrvatski 2014-05-08 2017-11-13
Deltyba : EPAR - All Authorised presentations HR = Hrvatski 2014-05-08 2017-11-13
Deltyba : EPAR - All Authorised presentations HR = Hrvatski 2014-05-08 2017-11-13
Deltyba : EPAR - All Authorised presentations HR = Hrvatski 2014-05-08 2017-11-13
Deltyba : EPAR - All Authorised presentations HR = Hrvatski 2014-05-08 2017-11-13
Deltyba : EPAR - All Authorised presentations HR = Hrvatski 2014-05-08 2017-11-13
Deltyba : EPAR - All Authorised presentations HR = Hrvatski 2014-05-08 2017-11-13
Deltyba : EPAR - All Authorised presentations HR = Hrvatski 2014-05-08 2017-11-13
Deltyba : EPAR - All Authorised presentations HR = Hrvatski 2014-05-08 2017-11-13
Deltyba : EPAR - All Authorised presentations HR = Hrvatski 2014-05-08 2017-11-13
Deltyba : EPAR - All Authorised presentations HR = Hrvatski 2014-05-08 2017-11-13
Deltyba : EPAR - All Authorised presentations HR = Hrvatski 2014-05-08 2017-11-13
Deltyba : EPAR - All Authorised presentations HR = Hrvatski 2014-05-08 2017-11-13
Deltyba : EPAR - All Authorised presentations HR = Hrvatski 2014-05-08 2017-11-13
Deltyba : EPAR - All Authorised presentations HR = Hrvatski 2014-05-08 2017-11-13
Deltyba : EPAR - All Authorised presentations HR = Hrvatski 2014-05-08 2017-11-13
Deltyba : EPAR - All Authorised presentations HR = Hrvatski 2014-05-08 2017-11-13
Deltyba : EPAR - All Authorised presentations HR = Hrvatski 2014-05-08 2017-11-13
Deltyba : EPAR - All Authorised presentations HR = Hrvatski 2014-05-08 2017-11-13
Deltyba : EPAR - All Authorised presentations HR = Hrvatski 2014-05-08 2017-11-13
Deltyba : EPAR - All Authorised presentations HR = Hrvatski 2014-05-08 2017-11-13
Deltyba : EPAR - All Authorised presentations HR = Hrvatski 2014-05-08 2017-11-13
Deltyba : EPAR - All Authorised presentations HR = Hrvatski 2014-05-08 2017-11-13
Deltyba : EPAR - All Authorised presentations HR = Hrvatski 2014-05-08 2017-11-13

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 2014-07-25 2018-08-03

Initial marketing-authorisation documents

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