The European Medicines Agency has been formally notified by La Jolla Limited of its decision to withdraw its application for a centralised marketing authorisation for the medicinal product Riquent (abetimus sodium).

Riquent was expected to be used to treat lupus nephritis, an inflammation of the kidneys, in patients with systemic lupus erythematosus (an auto-immune disease caused by the body's own defence system attacking normal tissue) who have a history of kidney disease. Riquent was expected to delay and to reduce the incidence of 'flares' (increased signs of kidney disease). Abetimus sodium was designated as an orphan medicinal product for the treatment of lupus nephritis on 20 November 2001.

The application for marketing authorisation for Riquent was submitted to the EMEA on 31 March 2006. 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 Riquent was due to the fact that the additional clinical data requested by the CHMP to support the application cannot be provided within the timeframe of the current application procedure.

More information about Riquent and the current 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 after the next meeting of the CHMP on 16-19 October 2006.



NOTES

1. Withdrawal of an application does not prejudice the possibility of a company making a new application at a later stage.

2. This press release, together with other information about the work of the EMEA, may be found on the EMEA website: emea.europa.eu

For further information please go to:
European Medicines Agency