UCB Pharma Withdraws Its Marketing Authorisation Application For Lacosamide Pain UCB Pharma, Europe

Main Category: Diabetes
Also Included In: Regulatory Affairs / Drug Approvals;  Pain / Anesthetics
Article Date: 28 Sep 2008 - 0:00 PDT

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The European Medicines Agency (EMEA) has been formally notified by UCB Pharma S.A. of its decision to withdraw the application for a centralised marketing authorisation for the medicine Lacosamide Pain UCB Pharma (lacosamide) film-coated tablets.

Lacosamide Pain UCB Pharma was expected to be used for the treatment of diabetic neuropathic pain in adults.

The application for marketing authorisation for Lacosamide Pain UCB Pharma was submitted to the EMEA on 15 August 2007. 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 Lacosamide Pain UCB Pharma was based on the view of the CHMP that a relevant effect of lacosamide in diabetic neuropathic pain has not been convincingly established.

More information about Lacosamide Pain UCB Pharma and the 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 in due course.

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 on the work of the EMEA, can be found on the EMEA website: http://www.emea.europa.eu

European Medicines Agency