Eisai announced Monday that the FDA issued a complete response letter regarding the application for a weekly transdermal version of Aricept (donepezil) for the treatment of mild, moderate and severe stages of Alzheimer’s disease. In its decision, the agency questioned usage of the patch.
The Japanese drugmaker said it will work with patch developer Teikoku Seiyaku to assess the agency's correspondence and determine its next steps. However, Eisai spokesman Takeshi Shimizu indicated that the company will not comment on whether further discussions with the FDA will delay sales of the patch, which had been projected to reach the market as early as June.
Eisai holds the marketing rights to the product in the US and if approved, will co-promote this dosing version with Pfizer. The company is looking to launch new formulations of Aricept in order to offset sales lost following the entry of generic versions of the compound in the US market.
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