GlaxoSmithKline Withdraws Its Marketing Authorisation Application For Bosatria (Mepolizumab)
LONDON, July 29, 2009--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.
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 is available: http://www.emea.europa.eu/pdfs/human/comp/opinion/029204en.pdf
3. This press release, together with other information on the work of the EMEA, can be found on the EMEA website: www.emea.europa.eu.