Egranli

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Questions and answers

On 4 November 2014, Teva Pharma 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 Egranli, for reduction in the duration of neutropenia and the occurrence of febrile neutropenia in adult cancer patients.

What is Egranli?

Egranli is a medicine that contains the active substance balugrastim. It was to be available as a solution for injection in prefilled syringes.

What was Egranli expected to be used for?

Egranli was to be used to reduce the duration of neutropenia (abnormally low level of neutrophils, a type of white blood cell that fights infection) and the occurrence of febrile neutropenia (neutropenia with fever) in adult cancer patients receiving cytotoxic chemotherapy (medicines that treat cancer by killing cells).

How is Egranli expected to work?

The active substance in Egranli, balugrastim, is made up of ‘granulocyte-colony-stimulating factor’ (G-CSF), a naturally occurring protein in the body that promotes the production of white blood cells including neutrophils in the bone marrow. The G-CSF in Egranli is attached to another natural blood protein called albumin, which decreases the rate at which G-CSF is removed from the body and allows the medicine to have a longer duration of action and to be given less often.

Balugrastim acts in the same way as naturally produced G-CSF, increasing the production of neutrophils and thereby helping to reduce the duration of neutropenia and to prevent febrile neutropenia (a sign of infection) in patients undergoing chemotherapy.

What did the company present to support its application?

Egranli was investigated in a main study in 304 breast cancer patients receiving chemotherapy, in which it was compared with another medicine containing a different long-acting G-CSF called pegfilgrastim. The main measure of effectiveness was the reduction in the duration of neutropenia and of the number of febrile neutropenia cases.

How far into the evaluation was the application when it was withdrawn?

The evaluation had finished and the CHMP had given a positive opinion. The company withdrew before the European Commission had issued a decision on this opinion.

What was the recommendation of the CHMP at that time?

Based on the review of the data, at the time of the withdrawal the CHMP had given a positive opinion, recommending that a marketing authorisation be granted for Egranli for the reduction of the duration of neutropenia and of the occurrence of febrile neutropenia.

What were the reasons given by the company for withdrawing the application?

In its letter notifying the Agency of the withdrawal of application, the company stated that it was withdrawing the application on the basis of its marketing strategy, and that it wished to focus on other projects. The withdrawal letter is available here.

What consequences does this withdrawal have for patients in clinical trials or compassionate use programmes?

The company informed the CHMP that there is no impact on patients as there are no ongoing clinical trials or compassionate use programmes using Egranli.

Name Language First published Last updated
Questions and answers on the withdrawal of the marketing authorisation application for Egranli (balugrastim) BG = bălgarski 2014-11-21 2015-02-16
Questions and answers on the withdrawal of the marketing authorisation application for Egranli (balugrastim) ES = español 2014-11-21 2015-02-16
Questions and answers on the withdrawal of the marketing authorisation application for Egranli (balugrastim) CS = čeština 2014-11-21 2015-02-16
Questions and answers on the withdrawal of the marketing authorisation application for Egranli (balugrastim) DA = dansk 2014-11-21 2015-02-16
Questions and answers on the withdrawal of the marketing authorisation application for Egranli (balugrastim) DE = Deutsch 2014-11-21 2015-02-16
Questions and answers on the withdrawal of the marketing authorisation application for Egranli (balugrastim) ET = eesti keel 2014-11-21 2015-02-16
Questions and answers on the withdrawal of the marketing authorisation application for Egranli (balugrastim) EL = elliniká 2014-11-21 2015-02-16
Questions and answers on the withdrawal of the marketing authorisation application for Egranli (balugrastim) EN = English 2014-11-21 2015-02-16
Questions and answers on the withdrawal of the marketing authorisation application for Egranli (balugrastim) FR = français 2014-11-21 2015-02-16
Questions and answers on the withdrawal of the marketing authorisation application for Egranli (balugrastim) IT = italiano 2014-11-21 2015-02-16
Questions and answers on the withdrawal of the marketing authorisation application for Egranli (balugrastim) LV = latviešu valoda 2014-11-21 2015-02-16
Questions and answers on the withdrawal of the marketing authorisation application for Egranli (balugrastim) LT = lietuvių kalba 2014-11-21 2015-02-16
Questions and answers on the withdrawal of the marketing authorisation application for Egranli (balugrastim) HU = magyar 2014-11-21 2015-02-16
Questions and answers on the withdrawal of the marketing authorisation application for Egranli (balugrastim) MT = Malti 2014-11-21 2015-02-16
Questions and answers on the withdrawal of the marketing authorisation application for Egranli (balugrastim) NL = Nederlands 2014-11-21 2015-02-16
Questions and answers on the withdrawal of the marketing authorisation application for Egranli (balugrastim) PL = polski 2014-11-21 2015-02-16
Questions and answers on the withdrawal of the marketing authorisation application for Egranli (balugrastim) PT = português 2014-11-21 2015-02-16
Questions and answers on the withdrawal of the marketing authorisation application for Egranli (balugrastim) RO = română 2014-11-21 2015-02-16
Questions and answers on the withdrawal of the marketing authorisation application for Egranli (balugrastim) SK = slovenčina 2014-11-21 2015-02-16
Questions and answers on the withdrawal of the marketing authorisation application for Egranli (balugrastim) SL = slovenščina 2014-11-21 2015-02-16
Questions and answers on the withdrawal of the marketing authorisation application for Egranli (balugrastim) FI = suomi 2014-11-21 2015-02-16
Questions and answers on the withdrawal of the marketing authorisation application for Egranli (balugrastim) SV = svenska 2014-11-21 2015-02-16
Questions and answers on the withdrawal of the marketing authorisation application for Egranli (balugrastim) HR = Hrvatski 2014-11-21 2015-02-16

News

Key facts

Product details for Egranli
NameEgranli
Product numberEMEA/H/C/002637
Date of issue of marketing authorisation valid throughout the European Union (if applicable)
International non-proprietary name or common name

balugrastim

Active substancebalugrastim
Date of withdrawal04/11/2014
Company making the application
Withdrawal typeInitial authorisation

All documents

Name Language First published Last updated
Withdrawal assessment report for Egranli (English only) 2015-02-16  
Questions and answers on the withdrawal of the marketing authorisation application for Egranli (balugrastim) BG = bălgarski 2014-11-21 2015-02-16
Questions and answers on the withdrawal of the marketing authorisation application for Egranli (balugrastim) ES = español 2014-11-21 2015-02-16
Questions and answers on the withdrawal of the marketing authorisation application for Egranli (balugrastim) CS = čeština 2014-11-21 2015-02-16
Questions and answers on the withdrawal of the marketing authorisation application for Egranli (balugrastim) DA = dansk 2014-11-21 2015-02-16
Questions and answers on the withdrawal of the marketing authorisation application for Egranli (balugrastim) DE = Deutsch 2014-11-21 2015-02-16
Questions and answers on the withdrawal of the marketing authorisation application for Egranli (balugrastim) ET = eesti keel 2014-11-21 2015-02-16
Questions and answers on the withdrawal of the marketing authorisation application for Egranli (balugrastim) EL = elliniká 2014-11-21 2015-02-16
Questions and answers on the withdrawal of the marketing authorisation application for Egranli (balugrastim) EN = English 2014-11-21 2015-02-16
Questions and answers on the withdrawal of the marketing authorisation application for Egranli (balugrastim) FR = français 2014-11-21 2015-02-16
Questions and answers on the withdrawal of the marketing authorisation application for Egranli (balugrastim) IT = italiano 2014-11-21 2015-02-16
Questions and answers on the withdrawal of the marketing authorisation application for Egranli (balugrastim) LV = latviešu valoda 2014-11-21 2015-02-16
Questions and answers on the withdrawal of the marketing authorisation application for Egranli (balugrastim) LT = lietuvių kalba 2014-11-21 2015-02-16
Questions and answers on the withdrawal of the marketing authorisation application for Egranli (balugrastim) HU = magyar 2014-11-21 2015-02-16
Questions and answers on the withdrawal of the marketing authorisation application for Egranli (balugrastim) MT = Malti 2014-11-21 2015-02-16
Questions and answers on the withdrawal of the marketing authorisation application for Egranli (balugrastim) NL = Nederlands 2014-11-21 2015-02-16
Questions and answers on the withdrawal of the marketing authorisation application for Egranli (balugrastim) PL = polski 2014-11-21 2015-02-16
Questions and answers on the withdrawal of the marketing authorisation application for Egranli (balugrastim) PT = português 2014-11-21 2015-02-16
Questions and answers on the withdrawal of the marketing authorisation application for Egranli (balugrastim) RO = română 2014-11-21 2015-02-16
Questions and answers on the withdrawal of the marketing authorisation application for Egranli (balugrastim) SK = slovenčina 2014-11-21 2015-02-16
Questions and answers on the withdrawal of the marketing authorisation application for Egranli (balugrastim) SL = slovenščina 2014-11-21 2015-02-16
Questions and answers on the withdrawal of the marketing authorisation application for Egranli (balugrastim) FI = suomi 2014-11-21 2015-02-16
Questions and answers on the withdrawal of the marketing authorisation application for Egranli (balugrastim) SV = svenska 2014-11-21 2015-02-16
Questions and answers on the withdrawal of the marketing authorisation application for Egranli (balugrastim) HR = Hrvatski 2014-11-21 2015-02-16
Withdrawal letter: Egranli (English only) 2014-11-21  

More information on Egranli

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').