La Jolla Pulls Riquent EU Marketing Application Due To Clinical Data Needs
This article was originally published in The Pink Sheet Daily
Executive Summary
Lupus renal disease treatment is still “approvable” in the U.S. pending submission of additional data to FDA.
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La Jolla Pharmaceutical has withdrawn its application for a European Union centralized marketing authorization application for Riquent (abetimus sodium) for lupus nephritis in patients with systemic lupus erythematosus who have a history of kidney disease, according to the European Medicines Agency. The decision to withdraw "was due to the fact that the additional clinical data requested by [EMEA's Committee for Medicinal Products for Human Use] to support the application cannot be provided within the timeframe of the current application procedure," La Jolla told EMEA in its official letter. Riquent has orphan drug status in both the EU and U.S. The firm received an "approvable" letter from FDA in 2004 recommending an additional study be conducted to distinguish Riquent from placebo through an endpoint such as time to renal flare; La Jolla said it will likely not submit that data before 2008. The application for Riquent was submitted to EMEA in March and was still under review by CHMP (1 (Also see "La Jolla Submits Riquent Application For Lupus In EU" - Pink Sheet, 22 Jun, 2006.)). - Brooke McManus ([email protected]) |