Beerse, Belgium, 12 July 2000 -- Reminyl (galantamine), a new treatment for Alzheimer's disease, was granted marketing approval under the Mutual Recognition Procedure by thirteen European Union member states as well as Norway and Iceland.
The countries mutually agreed to recognise the March approval of Reminyl (galantamine) by the Reference Member State, Sweden. Switzerland also received approval in June, following a separate application.
Novel Dual Mode of Action
Research indicates that Reminyl (galantamine), unlike other Alzheimer's treatments currently available, has a dual mechanism of action. Decreased levels of acetylcholine, caused by the death of acetylcholine neurones are known to be related to the symptoms of Alzheimer's disease. In addition to preserving levels of acetylcholine in the brain by blocking the action of the enzyme acetylcholinesterase (which inactivates acetylcholine), laboratory research has shown that Reminyl (galantamine) also appears to act on the brain's nicotinic receptors. The "modulation" of these receptors could lead to release of more acetylcholine. *1,2,3
Two phase III studies published this month in Neurology showed that treatment with Reminyl (galantamine) significantly improves cognition, global function and behavioural symptoms of Alzheimer's disease over a period of 1 year *4,5.
Reminyl (galantamine) is being developed by Janssen Pharmaceutica under a co-development agreement with UK-based Shire Pharmaceuticals Group plc.
"Reminyl(galantamine) can improve patient's cognition including language and memory and preserves the ability to perform daily tasks. These improvements are crucial to physicians, patients and caregivers alike. We are hopeful that this approval will make this new option treatment option accessible to many more patients in need," said Dr Alain Raoult, Vice President, Global Product Leader, CNS R&D, Janssen Research Foundation.