TORONTO, July 17 (Reuters) - Neurochem NRM.TO said on Tuesday that the U.S. Food and Drug Administration has asked for additional information on its Kiacta treatment for Amyloid A amyloidosis.
The company said the FDA had indicated that phase 2 and 3 clinical trials had shown evidence of the of the drug’s effectiveness in treating renal manifestations of amyloidosis, but that additional studies will be needed for approval.
Neurochem said it was disappointed, but that it will file a complete response to the FDA’s request in the near future.
Amyloid A Amyloidosis is a progressive and fatal condition that affects patients with chronic inflammatory disorders, Neurochem said. There is currently no approved therapeutical treatment and about half of all patients diagnosed with the disease die within five years.
((Reporting by Cameron French, editing by Rob Wilson; Reuters Messaging: firstname.lastname@example.org, 416-941-8199)) Keywords: NEUROCHEM/
C Reuters 2007. All rights reserved. Republication or redistribution ofReuters content, including by caching, framing or similar means, is expresslyprohibited without the prior written consent of Reuters. Reuters and the Reuterssphere logo are registered trademarks and trademarks of the Reuters group ofcompanies around the world.nN17243112