FDA approvable letter for Reminyl

Shire Pharmaceuticals (LSE:SHP; SHPGY) and Janssen Pharmaceutica received an approvable letter from the FDA for Reminyl galantamine, an acetylcholinesterase inhibitor to treat Alzheimer's disease. R&D director Wilson Totten told BioCentury that a U.S. launch in early 2001 was now well within schedule.

SHP and Janssen still need to resolve some labeling issues. It is not yet clear whether the FDA will allow mention of the proposed dual mode of action, which suggests that in addition to blocking acetylcholine destruction, Reminyl can make nicotinic receptors more sensitive to acetylcholine and so enhance the effects of elevating levels of the neurotransmitter. European authorities have indicated that they will allow mention of the dual mode of action on labels. Reminyl is approved in Europe, and European launches are anticipated for the fourth quarter. ...