Bosatria

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Questions and answers

On 28 July 2009, Glaxo Group Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Bosatria, for the treatment of adults with hypereosinophilic syndrome to reduce or eliminate the need for corticosteroid therapy and to reduce blood eosinophil counts.

What is Bosatria?

Bosatria is a powder that is made up into a solution for infusion (drip into a vein). It contains the active substance mepolizumab.

What was Bosatria expected to be used for?

Bosatria was expected to be used to treat adults with hypereosinophilic syndrome. This is a disease in which eosinophils (a type of white blood cell) start growing out of control, they accumulate in the tissues of many organs, and can cause damage to organs such as the heart, liver and lungs. Bosatria was expected to be used in patients who lack a gene called the ‘FIP1L1-PDGRF fusion gene’ to reduce or eliminate the need for the patients to be treated with corticosteroids (steroids used to treat the disease) and to reduce the level of eosinophils in the blood.

Bosatria was designated an ‘orphan medicine’ (a medicine to be used in rare diseases) on 29 July 2004 for the treatment of hypereosinophilic syndrome.

How is Bosatria expected to work?

The active substance in Bosatria, mepolizumab, is a monoclonal antibody. A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) that is found in the body. Mepolizumab has been designed to attach to a chemical messenger called interleukin 5 (IL-5), which is involved in the growth of eosinophils. By attaching to IL-5, mepolizumab was expected to reduce the accumulation of eosinophils in the blood, thereby relieving the symptoms of patients with hypereosinophilic syndrome.

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

The effects of Bosatria were first tested in experimental models before being studied in humans. In one main study involving 85 adults with hypereosinophilic syndrome, Bosatria was compared with placebo (a dummy treatment). All patients lacked the FIP1L1-PDGRF fusion gene and were receiving treatment with prednisone (a corticosteroid) that was helping to stabilise their symptoms. During the study the patients received either Bosatria or placebo while the amount of prednisone they received was gradually reduced. The main measure of effectiveness was the number of patients who could have their daily prednisone dose reduced to 10 mg or lower for a period of eight weeks.

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

The application was at day 180 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 issue a decision on this opinion.

What was the recommendation of the CHMP at that time?

Based on the review of the data and the company’s response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Bosatria could not have been approved for the treatment of adults with hypereosinophilic syndrome who lack the FIP1L1-PDGRF fusion gene, to reduce or eliminate the need for corticosteroid therapy and to reduce blood eosinophil counts.

What were the main concerns of the CHMP?

The CHMP was of the opinion that the main study did not provide sufficient evidence to show that Bosatria was effective in reducing the need for corticosteroid treatment. The CHMP was also concerned that the method used by the company to quantify the different forms of the active substance in the medicine was not appropriate. Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Bosatria did not outweigh its risks in the treatment of adults with hypereosinophilic syndrome who lack the FIP1L1-PDGRF fusion gene, to reduce or eliminate the need for corticosteroid therapy and to reduce blood eosinophil counts.

What were the reasons given by the company for withdrawing 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 withdrawal for patients in clinical trials or compassionate use programmes using Bosatria?

The company informed the CHMP that Bosatria will continue to be made available for patients in the open-label extension study and compassionate use programmes. If you are in a clinical trial or compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you.

Name Language First published Last updated
Questions and answers on the withdrawal of the marketing authorisation application for Bosatria (mepolizumab) BG = bălgarski 2009-08-20  
Questions and answers on the withdrawal of the marketing authorisation application for Bosatria (mepolizumab) ES = español 2009-08-20  
Questions and answers on the withdrawal of the marketing authorisation application for Bosatria (mepolizumab) CS = čeština 2009-08-20  
Questions and answers on the withdrawal of the marketing authorisation application for Bosatria (mepolizumab) DA = dansk 2009-08-20  
Questions and answers on the withdrawal of the marketing authorisation application for Bosatria (mepolizumab) DE = Deutsch 2009-08-20  
Questions and answers on the withdrawal of the marketing authorisation application for Bosatria (mepolizumab) ET = eesti keel 2009-08-20  
Questions and answers on the withdrawal of the marketing authorisation application for Bosatria (mepolizumab) EL = elliniká 2009-08-20  
Questions and answers on the withdrawal of the marketing authorisation application for Bosatria (mepolizumab) EN = English 2009-08-20  
Questions and answers on the withdrawal of the marketing authorisation application for Bosatria (mepolizumab) FR = français 2009-08-20  
Questions and answers on the withdrawal of the marketing authorisation application for Bosatria (mepolizumab) IT = italiano 2009-08-20  
Questions and answers on the withdrawal of the marketing authorisation application for Bosatria (mepolizumab) LV = latviešu valoda 2009-08-20  
Questions and answers on the withdrawal of the marketing authorisation application for Bosatria (mepolizumab) LT = lietuvių kalba 2009-08-20  
Questions and answers on the withdrawal of the marketing authorisation application for Bosatria (mepolizumab) HU = magyar 2009-08-20  
Questions and answers on the withdrawal of the marketing authorisation application for Bosatria (mepolizumab) MT = Malti 2009-08-20  
Questions and answers on the withdrawal of the marketing authorisation application for Bosatria (mepolizumab) NL = Nederlands 2009-08-20  
Questions and answers on the withdrawal of the marketing authorisation application for Bosatria (mepolizumab) PL = polski 2009-08-20  
Questions and answers on the withdrawal of the marketing authorisation application for Bosatria (mepolizumab) PT = português 2009-08-20  
Questions and answers on the withdrawal of the marketing authorisation application for Bosatria (mepolizumab) RO = română 2009-08-20  
Questions and answers on the withdrawal of the marketing authorisation application for Bosatria (mepolizumab) SK = slovenčina 2009-08-20  
Questions and answers on the withdrawal of the marketing authorisation application for Bosatria (mepolizumab) SL = slovenščina 2009-08-20  
Questions and answers on the withdrawal of the marketing authorisation application for Bosatria (mepolizumab) FI = suomi 2009-08-20  
Questions and answers on the withdrawal of the marketing authorisation application for Bosatria (mepolizumab) SV = svenska 2009-08-20  

Press release

GlaxoSmithKline withdraws its marketing authorisation application for Bosatria (mepolizumab)

The European Medicines Agency has been formally notified by GlaxoSmithKline Research & Development Limited of its decision to withdraw the application for a centralised marketing authorisation for Bosatria (mepolizumab), powder for solution for infusion, 250 mg/vial.

Bosatria was expected to be used for the treatment of hypereosinophilic syndrome (HES) in adult patients without the FIP1L1-PDGFR fusion gene, to reduce or eliminate the need for corticosteroid therapy and to reduce blood eosinophil counts. HES is a rare group of disorders. People suffering from HES have a large amount of white blood cells, called eosinophils, in the blood and tissue for which there is no known cause. The build-up of eosinophils can cause damage to the heart, central nervous system, blood, lungs, skin, stomach and intestines.

The application for the marketing authorisation for Bosatria was submitted to the Agency on 1 September 2008. At the time of withdrawal it was under review by the Agency’s Committee for Medicinal Products for Human Use (CHMP). Bosatria was designated as an orphan medicine on 29 July 2004.

The company stated in its official letter that the decision to withdraw the application for Bosatria was based on the CHMP’s view that the data available to date did not allow the Committee to conclude on a positive benefit-risk balance for Bosatria in the applied indication.

More information about the withdrawal of Bosatria 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 Agency’s website in due course.

--ENDS--

Notes
1. Withdrawal of an application does not prejudice the possibility of a company making a new application at a later stage.
2. More information on the orphan designation for mepolizumab for the treatment of hypereosinophilic syndrome.

Name Language First published Last updated
GlaxoSmithKline withdraws its marketing authorisation application for Bosatria (English only) 2009-07-29  

Key facts

Product details for Bosatria
NameBosatria
Product numberEMEA/H/C/001069
Date of issue of marketing authorisation valid throughout the European Union (if applicable)
International non-proprietary name or common name

mepolizumab

Active substancemepolizumab
Date of withdrawal28/07/2009
Company making the application

Glaxo Group Limited

Withdrawal typeInitial authorisation

All documents

Name Language First published Last updated
Withdrawal assessment report for Bosatria (English only) 2009-07-23  
Withdrawal letter : Bosatria (English only) 2009-07-28  
Questions and answers on the withdrawal of the marketing authorisation application for Bosatria (mepolizumab) BG = bălgarski 2009-08-20  
Questions and answers on the withdrawal of the marketing authorisation application for Bosatria (mepolizumab) ES = español 2009-08-20  
Questions and answers on the withdrawal of the marketing authorisation application for Bosatria (mepolizumab) CS = čeština 2009-08-20  
Questions and answers on the withdrawal of the marketing authorisation application for Bosatria (mepolizumab) DA = dansk 2009-08-20  
Questions and answers on the withdrawal of the marketing authorisation application for Bosatria (mepolizumab) DE = Deutsch 2009-08-20  
Questions and answers on the withdrawal of the marketing authorisation application for Bosatria (mepolizumab) ET = eesti keel 2009-08-20  
Questions and answers on the withdrawal of the marketing authorisation application for Bosatria (mepolizumab) EL = elliniká 2009-08-20  
Questions and answers on the withdrawal of the marketing authorisation application for Bosatria (mepolizumab) EN = English 2009-08-20  
Questions and answers on the withdrawal of the marketing authorisation application for Bosatria (mepolizumab) FR = français 2009-08-20  
Questions and answers on the withdrawal of the marketing authorisation application for Bosatria (mepolizumab) IT = italiano 2009-08-20  
Questions and answers on the withdrawal of the marketing authorisation application for Bosatria (mepolizumab) LV = latviešu valoda 2009-08-20  
Questions and answers on the withdrawal of the marketing authorisation application for Bosatria (mepolizumab) LT = lietuvių kalba 2009-08-20  
Questions and answers on the withdrawal of the marketing authorisation application for Bosatria (mepolizumab) HU = magyar 2009-08-20  
Questions and answers on the withdrawal of the marketing authorisation application for Bosatria (mepolizumab) MT = Malti 2009-08-20  
Questions and answers on the withdrawal of the marketing authorisation application for Bosatria (mepolizumab) NL = Nederlands 2009-08-20  
Questions and answers on the withdrawal of the marketing authorisation application for Bosatria (mepolizumab) PL = polski 2009-08-20  
Questions and answers on the withdrawal of the marketing authorisation application for Bosatria (mepolizumab) PT = português 2009-08-20  
Questions and answers on the withdrawal of the marketing authorisation application for Bosatria (mepolizumab) RO = română 2009-08-20  
Questions and answers on the withdrawal of the marketing authorisation application for Bosatria (mepolizumab) SK = slovenčina 2009-08-20  
Questions and answers on the withdrawal of the marketing authorisation application for Bosatria (mepolizumab) SL = slovenščina 2009-08-20  
Questions and answers on the withdrawal of the marketing authorisation application for Bosatria (mepolizumab) FI = suomi 2009-08-20  
Questions and answers on the withdrawal of the marketing authorisation application for Bosatria (mepolizumab) SV = svenska 2009-08-20  
GlaxoSmithKline withdraws its marketing authorisation application for Bosatria (English only) 2009-07-29  

Related information

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').