Eisai gains Philippines approval for Aricept in new license

Brain imaging

Seventeen years after the Philippines first approved Eisai and Pfizer’s ($PFE) Alzheimer’s drug Aricept, the country has now granted a new license for patients with Lewy body dementia.

Specifically, Tokyo-based Eisai has been granted the green light in the country for the symptomatic treatment of dementia with Lewy bodies (DLB) for its anti-Alzheimer's agent Aricept (donepezil hydrochloride).

DLB shares symptoms with both Alzheimer's disease and Parkinson’s disease, and may account for around 10% of all cases of dementia. It is often undiagnosed, according to the Alzheimer’s Society.

This follows the very first approval of Aricept for DLB in Japan in September 2014, making the Philippines only the second country in which Aricept has gained this license.

An application seeking approval for DLB is based on clinical trial data from Japan first submitted in November 2015. An application seeking approval of Aricept for the treatment of DLB is also underway via a regulatory review in Thailand.

DLB is considered to be one of the major types of dementia worldwide, alongside Alzheimer's disease and vascular dementia, according to Eisai.

It says that DLB is difficult to diagnose because the disease presents characteristic symptoms such as cognitive fluctuations, visual hallucinations and Parkinsonism in addition to progressive cognitive impairment.

The number of dementia patients in the Philippines is estimated to be around 400,000.

Pfizer and Eisai co-market the drug across certain regions. Aricept has begun losing patents in some countries, including the U.K., where generics are now available.

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