Non-Approvable Letter For Memantine in Mild Alzheimer’s Disease
The FDA has issued a non-approvable letter to Forest Laboratories in response to its supplemental New Drug Application (sNDA) to expand the indication of memantine HCl (Namenda®) to include the treatment of mild Alzheimer’s disease (AD). Memantine was approved for the treatment of moderate-to-severe AD in October 2003.
After the FDA accepted the sNDA for review in November 2004, the agency informed Forest that a single positive study in patients with mild-to-moderate AD would be adequate to extend the drug’s indication. The FDA also acknowledged that the six-month trial for mild-to-moderate AD, which reached statistical significance at the required primary end-points, was such a study. However, the FDA then decided not to approve the mild AD indication. Forest plans to meet with the FDA to discuss the letter.
cetirizine allergy
Currently, all AD medications approved in the U.S.—other than meman-tine—belong to a class of agents called acetylcholinesterase inhibitors, which are indicated only for mild-to-moderate symptoms. Memantine can be used alone or in combination with an acetyl-cholinesterase inhibitor in the moderate and severe stages.
