Trials Show Higher Death Rate Among Some Test Subjects Using ReminylJan 22, 2005 | AP
Patients taking Alzheimer's drug Reminyl in a test for another use had higher death rates than those taking a placebo, Johnson & Johnson Pharmaceutical Research & Development LLC announced Friday.
The patients had mild cognitive impairment, and the J&J company is no longer pursuing Reminyl as a treatment for the condition and has not submitted any applications for such use, spokeswoman Carol Goodrich said.
Reminyl was approved in 2001 as a treatment for mild to moderate Alzheimer's disease. The higher death rate was not observed in Alzheimer's trials, Goodrich said.
While mild cognitive impairment can be a precursor to Alzheimer's disease, it does not always progress to dementia or Alzheimer's, she said.
"The health authorities that are reviewing this data ... are still supporting its use for the approved indication, which is mild to moderate Alzheimer's disease," Goodrich said. It is approved in 69 nations for that use. The number of users was not available, she said.
The company is analyzing the data and is discussing it with regulators.
The Raritan-based company said it presented the information to authorities worldwide over the summer, and at two medical conferences. Friday's announcement was made as authorities in Canada and Europe were to disclose the information, she said.
The investigational studies involved 2,000 patients in 16 countries over two years. Mortality rates were low in both the Reminyl and placebo groups, compared to expected rates in this population or in patients with Alzheimer's disease. Of 20 deaths, 15 were among the group taking Reminyl, the company said.
J&JPRD developed Reminyl with Shire Pharmaceuticals Group PLC. Janssen Pharmaceutica Products LP manufactures and markets it in the United States.