Axxonis Pharma AG Withdraws Its Marketing Authorisation Application For Nenad (lisuride), Europe

Main Category: Restless Legs Syndrome
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 03 Dec 2009 - 15:00 PDT

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The European Medicines Agency has been formally notified by Axxonis Pharma AG of its decision to withdraw its application for a centralised marketing authorisation for the medicine Nenad (lisuride), 2.5 and 5.0 microgram/h transdermal patch.

Nenad was expected to be used in adults with moderate-to-severe idiopathic restless legs syndrome.

The application for the marketing authorisation for Nenad was submitted to the Agency on 12 May 2008. Nenad received a negative opinion from the Committee for Medicinal Products for Human Use (CHMP) on 19 November 2009 and at the time of withdrawal a European Commission decision was pending.

In its official letter, the company stated that the withdrawal of the application was based on the CHMP's view that the data provided do not allow the Committee to conclude on a positive benefit-risk balance in the claimed indication.

More information about Nenad will be made available in a question-and-answer document. This document, together with the assessment report and the withdrawal letter from the company, will be published on the Agency's website after the next CHMP meeting of 14-17 of December 2009.

Notes

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

2. The question and answer document on the negative opinion for Nenad can be found here.

Source
European Medicines Agency

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