Neurochem Withdraws Its Marketing Authorisation Application For Kiacta(eprodisate Disodium), Europe

The European Medicines Agency (EMEA) has been formally notified by
Neurochem Luxco II SARL of its decision to withdraw the application for
a centralised marketing authorisation for the medicine Kiacta
(eprodisate disodium) capsules.


Kiacta was expected to be used for the treatment of amyloid A
amyloidosis, a rare, life-threatening disease that occurs in patients
with long-lasting inflammation, most commonly due to rheumatoid
arthritis.


The application for marketing authorisation for Kiacta was submitted to
the EMEA on 4 September 2006. The Agency's Committee for Medicinal
Products for Human Use (CHMP) had given a negative opinion recommending
the refusal of the marketing authorisation on 13 December 2007. The
company had requested a re-examination of the negative opinion. The
re-examination had not yet finished when the company withdrew.


In its official letter, the company stated that the withdrawal of Kiacta
was based on the request by the CHMP for an additional
placebo-controlled study, which the company is not able to provide
within the timeframe allowed by the centralised procedure.


More information about Kiacta 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.

European Medicines Agency