Mar
The European Medicines Agency (EMEA) has been formally notified byNeurochem Luxco II SARL of its decision to withdraw the application fora centralised marketing authorisation for the medicine Kiacta(eprodisate disodium) capsules.
Kiacta was expected to be used for the treatment of amyloid Aamyloidosis, a rare, life-threatening disease that occurs in patientswith long-lasting inflammation, most commonly due to rheumatoidarthritis.
The application for marketing authorisation for Kiacta was submitted tothe EMEA on 4 September 2007. The Agency’s Committee for MedicinalProducts for Human Use (CHMP) had given a negative opinion recommendingthe refusal of the marketing authorisation on 13 December 2007. Thecompany had requested a re-examination of the negative opinion. There-examination had not yet finished when the company withdrew.
In its official letter, the company stated that the withdrawal of Kiactawas based on the request by the CHMP for an additionalplacebo-controlled study, which the company is not able to providewithin the timeframe allowed by the centralised procedure.
More information about Kiacta and the state of the scientific assessmentat the time of withdrawal will be made available in aquestion-and-answer document. This document, together with thewithdrawal letter from the company, will be published on the EMEAwebsite in due course.
Notes:
1. Withdrawal of an application does not prejudice the possibilityof a company making a new application at a later stage.
European Medicines Agency