Eisai got an FDA untitled letter for two Aricept TV ads that the agency said overstate the efficacy of the drug.
The ads, “Beach” and “Garden,” feature women recounting seeing the signs of advancing dementia in parents with Alzheimer's. “Dad had been repeating things and acting disoriented for a while, like something was stealing him away from us,” says a woman in “Beach.” After treatment with Aricept, the man is shown engaging vigorously with family members.
Each ad implied “a greater benefit than has been supported by substantial evidence or substantial clinical experience,” said the agency's DDMAC. Both ads, said the February 3 letter, start out “presenting patients with Alzheimer's disease looking blank, confused, distant and walking off apart from their family members. However, after talking to their doctors about treatment with Aricept, the patients are seen interacting and communicating with their family members, happily and actively involved in activities with them. These presentations imply that, as a result of Aricept treatment, patients' cognitive and daily functioning, specifically aspects of attention and focus, orientation, communication and social interaction and engagement, will be restored to normal.” The FDA requested that Eisai pull the ads and submit a response.
Eisai said in a statement: “We will give careful consideration to the FDA's comments and will respond in the requested timeframe.”