Overview

Deltyba is a medicine that is used in adults, adolescents, children and infants weighing at least 10 kg who have 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. Further information on the orphan designation can be found here: ema.europa.eu/en/medicines/human/orphan-designations/eu307524

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 50 mg tablets and 25 mg dispersible tables which are taken with food. The 25 mg dispersible tablets are only for children and infants weighing between 10 and 30 kg. The recommended dose for adults is 100 mg twice a day, while the dose for children and infants depends on the patient’s body weight.

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.

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.

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.

Additional data indicate that the medicine will be as effective in children, including infants, as it is in adults.

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.

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.

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.

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.

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

Deltyba : EPAR - Medicine overview

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Deltyba : EPAR - Risk management plan

Product information

Deltyba : EPAR - Product Information

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Latest procedure affecting product information: R/0070

26/02/2024

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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).

Deltyba : EPAR - All Authorised presentations

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lietuvių kalba (LT) (40.37 KB - PDF)
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Product details

Name of medicine
Deltyba
Active substance
Delamanid
International non-proprietary name (INN) or common name
delamanid
Therapeutic area (MeSH)
Tuberculosis, Multidrug-Resistant
Anatomical therapeutic chemical (ATC) code
J04AK06

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 adults, adolescents, children and infants with a body weight of at least 10 kg when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability (see sections 4.2, 4.4 and 5.1).

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

Authorisation details

EMA product number
EMEA/H/C/002552

Additional monitoring

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

Conditional approval

This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.

Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Marketing authorisation holder
Otsuka Novel Products GmbH

Erika-Mann-Strasse 21
D-80636 München
Germany

Opinion adopted
21/11/2013
Marketing authorisation issued
27/04/2014
Revision
26

Assessment history

Deltyba : EPAR - Procedural steps taken and scientific information after authorisation

Deltyba-H-C-PSUSA-00010213-202304: EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Deltyba-H-C-PSUSA-00010213-202104 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Deltyba-H-C-002552-X-0046-G : EPAR - Assessment report - Variation

CHMP post-authorisation summary of positive opinion for Deltyba (X-46-G)

Deltyba-H-C-2552-II-0040 : EPAR - Assessment report - Variation

CHMP post-authorisation summary of positive opinion for Deltyba (II-40)

Deltyba-PSUSA-00010213-201810 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)

Deltyba-H-C-2552-P46-007 : EPAR - Assessment report

Deltyba : EPAR - Public assessment report

CHMP summary of positive opinion for Deltyba

Questions and answers on refusal of the marketing authorisation for Delamanid

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