Namenda was approved by the FDA for the treatment of moderate to severe Alzheimer’s disease in October 2003. However, the US regulator has now raised questions regarding the drug’s efficacy in treating the mild form of the disease.
Forest based its supplemental new drug application on a six-month US study which showed that Namenda reached statistical significance in treating mild Alzheimer’s disease. However, the company says that the FDA decided not to approve the expanded indication due to two earlier studies in which
Namenda did not achieve statistical significance.
Forest plans to meet with the FDA to further discuss the non-approvable letter. The company also indicated that the non-approvable status of Namenda for mild Alzheimer’s disease would not impact its current earnings per share guidance of $2.30 for the fiscal year ending March 31, 2006.
“Namenda offers a well tolerated and effective treatment option to the millions of Americans suffering with moderate or severe Alzheimer’s disease,” said Dr Ivan Gergel, vice president of scientific affairs at Forest Laboratories.