Vibativ

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Questions and answers

On 20 October 2008, Astellas Pharma Europe B. V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Vibativ, for the treatment of complicated skin and soft tissue infections in adults.

What is Vibativ?

Vibativ is a powder to be made up into a solution for infusion (drip into a vein). It contains the active substance telavancin.

What was Vibativ expected to be used for?

Vibativ was expected to be used to treat adults with complicated infections of the skin and the ‘soft tissues’ below the skin. ‘Complicated’ means that the infection is difficult to treat, because it has spread to the deep tissues below the skin, treatment with surgery might be needed, or the patient has other conditions that might affect the response to treatment.

Vibativ was to be used only when the infection was known or thought to be caused by types of bacteria that are classified as ‘Gram-positive’. These include Staphylococcus aureus (including ‘methicillin-resistant’ forms known as ‘MRSA’) and Streptococcus pyogenes.

How is Vibativ expected to work?

The active substance in Vibativ, telavancin, is an antibiotic that belongs to the group ‘glycopeptides’. It is expected to work in two ways, both by stopping the bacteria making their cell walls and by disrupting their cell membranes. Together, the cell wall and membrane form a barrier between the bacterial cell contents and the external environment. By disrupting this barrier, telavancin is expected to kill the bacteria that are causing the infection.

What documentation did the company present to support its application to the CHMP?

The effects of Vibativ were first tested in experimental models before being studied in humans.

Vibativ was compared with vancomycin (another antibiotic) in two main studies involving a total of 2,079 adults with complicated skin and soft tissue infections due to Gram-positive bacteria. The studies were carried out at sites where infection with MRSA is common. The antibiotics were given for up to 14 days. The main measure of effectiveness was the number of patients whose infection had been cured after the end of treatment.

How far into the evaluation was the application when it was withdrawn?

The application was at day 201 when the company withdrew. After the CHMP had assessed the responses from the company to a list of questions, there were still some unresolved issues outstanding.

The CHMP normally takes up to 210 days to evaluate a new application. Based on the review of the initial documentation, the CHMP prepares a list of questions at day 120, which is sent to the company. Once the company has supplied responses to the questions, the CHMP reviews them and may, before giving an opinion, ask any remaining questions at day 180. Following the CHMP’s opinion, it usually takes around two months for the European Commission to grant a licence.

What was the recommendation of the CHMP at that time?

Based on the review of the data and the company’s responses to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Vibativ could not have been approved for the treatment of complicated skin and soft tissue infections in adults.

What were the main concerns of the CHMP?

The CHMP was concerned that there was no additional benefit of Vibativ over vancomycin, and could cause more kidney damage than vancomycin. The Committee was also concerned that Vibativ may cause ‘QTc prolongation’ (an alteration of the electrical activity of the heart). The CHMP also had concerns regarding the production of the medicine, its stability and the possible presence of impurities.

At that point in time, the CHMP was of the opinion that the benefits of Vibativ in the treatment of complicated skin and soft tissue infections in adults did not outweigh its risks. Hence, the CHMP recommended that Vibativ be refused marketing authorisation.

What were the reasons given by the company to withdraw the application?

The letter from the company notifying the EMEA of the withdrawal of the application is available under the tab 'All documents'.

What are the consequences of the refusal for patients in clinical trials or compassionate use programmes using Vibativ?

The company informed the CHMP that there are currently no clinical trials or compassionate use programmes ongoing with Vibativ.

Name Language First published Last updated
Questions and answers on the withdrawal of the marketing application for Vibativ BG = bălgarski 2008-11-28  
Questions and answers on the withdrawal of the marketing application for Vibativ ES = español 2008-11-28  
Questions and answers on the withdrawal of the marketing application for Vibativ CS = čeština 2008-11-28  
Questions and answers on the withdrawal of the marketing application for Vibativ DA = dansk 2008-11-28  
Questions and answers on the withdrawal of the marketing application for Vibativ DE = Deutsch 2008-11-28  
Questions and answers on the withdrawal of the marketing application for Vibativ ET = eesti keel 2008-11-28  
Questions and answers on the withdrawal of the marketing application for Vibativ EL = elliniká 2008-11-28  
Questions and answers on the withdrawal of the marketing application for Vibativ EN = English 2008-11-28  
Questions and answers on the withdrawal of the marketing application for Vibativ FR = français 2008-11-28  
Questions and answers on the withdrawal of the marketing application for Vibativ IT = italiano 2008-11-28  
Questions and answers on the withdrawal of the marketing application for Vibativ LV = latviešu valoda 2008-11-28  
Questions and answers on the withdrawal of the marketing application for Vibativ LT = lietuvių kalba 2008-11-28  
Questions and answers on the withdrawal of the marketing application for Vibativ HU = magyar 2008-11-28  
Questions and answers on the withdrawal of the marketing application for Vibativ MT = Malti 2008-11-28  
Questions and answers on the withdrawal of the marketing application for Vibativ NL = Nederlands 2008-11-28  
Questions and answers on the withdrawal of the marketing application for Vibativ PL = polski 2008-11-28  
Questions and answers on the withdrawal of the marketing application for Vibativ PT = português 2008-11-28  
Questions and answers on the withdrawal of the marketing application for Vibativ RO = română 2008-11-28  
Questions and answers on the withdrawal of the marketing application for Vibativ SK = slovenčina 2008-11-28  
Questions and answers on the withdrawal of the marketing application for Vibativ SL = slovenščina 2008-11-28  
Questions and answers on the withdrawal of the marketing application for Vibativ FI = suomi 2008-11-28  
Questions and answers on the withdrawal of the marketing application for Vibativ SV = svenska 2008-11-28  

Press release

Astellas withdraws its marketing authorisation application for Vibativ (telavancin)

The European Medicines Agency (EMEA) has been formally notified by Astellas Pharma Europe B.V. of its decision to withdraw the application for a centralised marketing authorisation for the medicinal product Vibativ (telavancin) 15 mg/ml powder for concentrate for solution for infusion.

Vibativ was expected to be used for the treatment of complicated skin and soft tissue infections in adults.

The application for marketing authorisation for Vibativ was submitted to the EMEA on 2 May 2007. At the time of the withdrawal, it was under review by the Agency’s Committee for Medicinal Products for Human Use (CHMP).

In its official letter, the company stated that the withdrawal of Vibativ was based on the CHMP’s communication that the data provided were not sufficient to allow it to conclude a positive benefit-risk balance for Vibativ for the applied indication at that time.

More information about Vibativ and the state of the scientific assessment at the time of withdrawal will be made available in a question-and-answer document. This document, together with the withdrawal letter from the company, will be published on the EMEA website in due course.

Note

  • Withdrawal of an application does not prejudice the possibility of a company making a new application at a later stage.
Name Language First published Last updated
Astellas withdraws its marketing authorisation application for Vibativ (telavancin) (English only) 2008-10-24  

Key facts

Product details for Vibativ
NameVibativ
Product numberEMEA/H/C/000864
Date of issue of marketing authorisation valid throughout the European Union (if applicable)
International non-proprietary name or common name

telavancin

Active substancetelavancin
Date of withdrawal20/10/2008
Company making the application

Astellas Pharma Europe B. V.

Withdrawal typeInitial authorisation

All documents

Name Language First published Last updated
Withdrawal letter : Vibativ (English only) 2008-10-20  
Questions and answers on the withdrawal of the marketing application for Vibativ BG = bălgarski 2008-11-28  
Questions and answers on the withdrawal of the marketing application for Vibativ ES = español 2008-11-28  
Questions and answers on the withdrawal of the marketing application for Vibativ CS = čeština 2008-11-28  
Questions and answers on the withdrawal of the marketing application for Vibativ DA = dansk 2008-11-28  
Questions and answers on the withdrawal of the marketing application for Vibativ DE = Deutsch 2008-11-28  
Questions and answers on the withdrawal of the marketing application for Vibativ ET = eesti keel 2008-11-28  
Questions and answers on the withdrawal of the marketing application for Vibativ EL = elliniká 2008-11-28  
Questions and answers on the withdrawal of the marketing application for Vibativ EN = English 2008-11-28  
Questions and answers on the withdrawal of the marketing application for Vibativ FR = français 2008-11-28  
Questions and answers on the withdrawal of the marketing application for Vibativ IT = italiano 2008-11-28  
Questions and answers on the withdrawal of the marketing application for Vibativ LV = latviešu valoda 2008-11-28  
Questions and answers on the withdrawal of the marketing application for Vibativ LT = lietuvių kalba 2008-11-28  
Questions and answers on the withdrawal of the marketing application for Vibativ HU = magyar 2008-11-28  
Questions and answers on the withdrawal of the marketing application for Vibativ MT = Malti 2008-11-28  
Questions and answers on the withdrawal of the marketing application for Vibativ NL = Nederlands 2008-11-28  
Questions and answers on the withdrawal of the marketing application for Vibativ PL = polski 2008-11-28  
Questions and answers on the withdrawal of the marketing application for Vibativ PT = português 2008-11-28  
Questions and answers on the withdrawal of the marketing application for Vibativ RO = română 2008-11-28  
Questions and answers on the withdrawal of the marketing application for Vibativ SK = slovenčina 2008-11-28  
Questions and answers on the withdrawal of the marketing application for Vibativ SL = slovenščina 2008-11-28  
Questions and answers on the withdrawal of the marketing application for Vibativ FI = suomi 2008-11-28  
Questions and answers on the withdrawal of the marketing application for Vibativ SV = svenska 2008-11-28  
Astellas withdraws its marketing authorisation application for Vibativ (telavancin) (English only) 2008-10-24  

More information on Vibativ

The applicant initially withdrew its marketing authorisation application for this medicine. Following a later application by the company, the European Commission granted a marketing authorisation for the medicine.

Related information on withdrawals

The question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the medicine at the time of the withdrawal of the application, and includes a link to the company's formal withdrawal letter.

An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').