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Back To Vidyya New Alzheimer's Treatment ReminylTM(Galantamine) Completes EU Mutual Recognition Procedure

Drug Will Be Available In EU Nations As Early AS Fourth Quarter 2000

Shire Pharmaceuticals Group plc and Janssen Pharmaceutica today announce that ReminylTM (galantamine), a new treatment for Alzheimer's disease, has successfully completed the Mutual Recognition Procedure.

Thirteen EU countries, as well as Norway and Iceland, have mutually agreed to recognize the early approval of ReminylTM by the Reference Member State, Sweden. Switzerland also received approval in June, following a separate application. ReminylTM will be available to doctors to prescribe for their patients from the fourth quarter 2000, following completion, where necessary, of certain administrative procedures.

ReminylTM is being developed by the Janssen Research Foundation and Shire under a co-development and licensing agreement. ReminylTM will be registered and marketed by Shire in the United Kingdom and Ireland under a co-promotion agreement with Janssen-Cilag. Elsewhere in Europe, Janssen-Cilag will market the product.

The European Summary of Product Characteristics (SmPC) indicates that galantamine has a novel dual mechanism of action(7). 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 suggests that galantamine may also act on the brain's nicotinic receptors. The "modulation" of these receptors may lead to release of more acetylcholine(1,2,3). Janssen Research Foundation is investigating the clinical significance of this characteristic further.

Two Phase III studies published this month in Neurology showed that treatment with ReminylTM significantly benefits the cognitive, functional and behavioural symptoms of patients with mild to moderately severe Alzheimer's disease. Moreover, cognitive and daily function were maintained for 12 months(4,5). Adverse side effects experienced by study participants were mostly gastrointestinal in nature and were reported as mild and temporary. Side effects that were reported at least five percent more often by patients taking galantamine as by those receiving placebo included nausea and diarrhea (13% vs. 5% and 12% vs. 6% respectively).

Submissions seeking regulatory marketing approvals have also been made to the regulatory health authorities in Canada, Australia, Poland, South Africa and New Zealand during the second quarter of 1999 and to the US Food and Drug Administration (FDA) at the end of September 1999. Marketing approvals in all the aforementioned countries have not yet been received.

"We are proud to announce that ReminylTM has received approval in Europe," said Dr. Alain Raoult, Vice President, Global Product Leader, CNS R&D, Janssen Research Foundation. "We hope ReminylTM will improve the lives of patients and caregivers affected by Alzheimer's disease."

"We are particularly pleased with the overall spectrum of effects of ReminylTM covering behavioural symptoms and benefits to caregivers, in addition to the traditional cognitive benefits," says Dr Wilson Totten, Group R&D Director at Shire Pharmaceuticals Group plc.


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Editor: Susan K. Boyer, RN
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