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news.Eisai has submitted a supplemental new drug application to the FDA for Aricept for treatment of severe Alzheimer's disease. Aricept, which is co-promoted in the US by Eisai and Pfizer is currently approved for treatment of only mild to moderate Alzheimer's.
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“Our goal to provide Aricept to people with severe Alzheimer’s disease is consistent with Eisai’s human health care mission to improve the lives of patients and their families,” said Lonnel Coats, president and COO of Eisai.
The submission is based on data from a six-month, multi-center, placebo-controlled clinical trial conducted in approximately 250 nursing home patients with severe Alzheimer’s disease. In the pivotal study, patients with the severe form of the disease treated with Aricept had a statistically significant improvement compared to those taking placebo on both primary measures of efficacy.
The most common adverse events in Aricept treated patients reported at more than twice the rate of placebo-treated patients were diarrhea and hallucinations. The rate of discontinuation for adverse events was greater in the Aricept treated patients than in the placebo-treated patients.
Alzheimer’s disease is a progressive brain disease that is said to affect 4.5 million Americans. Aricept is believed to work by inhibiting the breakdown of ACh, thereby increasing available levels of this chemical in the brain.