Lux Biosciences Withdraws Marketing Authorisation Application for Luveniq
The company stated that they were unable to demonstrate to the satisfaction of the CHMP an overwhelming effect showing that the benefits of Luveniq outweigh its risks, and thus would qualify for a recommendation for authorisation with one pivotal study only.
The European Medicines Agency has been formally notified by Lux Biosciences GmbH of its decision to withdraw its application for a centralised marketing authorisation for the medicine Luveniq (voclosporin), 10 mg soft capsules.
The application for the marketing authorisation for Luveniq was initially submitted to the Agency on 10 February 2010 and the medicine received a negative opinion by the Committee for Medicinal Products for Human Use (CHMP) on 23 June 2011. The company submitted a re-examination request for Luveniq on 8 July 2011. At the time of the withdrawal it was under review by the CHMP.
In its official letter, the company stated that they were unable to demonstrate to the satisfaction of the CHMP an overwhelming effect showing that the benefits of Luveniq outweigh i
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