Post by norbert1 on Dec 19, 2006 8:49:24 GMT -5
Forum members,
Aricept has been officially approved for severe Alzheimers.
Background - the original approval was based on 6 month trials and was approved for mild to moderate alzheimers. Based on the trials, People often would believe that aricept only worked for 6 months and some insurance companies would approve Aricept only for six months.
Later, aricept ads would cite a study that aricept provided benefits for up over 5 years.
I also have seen a few posts were people with late stage alzheimers developed swallowing problems shortly after discontinuing aricept.
Now comes word that Aricept has been formally approved for severe Alzheimers.
ARICEPT FOR TREATMENT OF SEVERE ALZHEIMER'S (submitted)
September 6, 2005
(Source: Medical News Today) – Eisai Medical Research has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration for Aricept® (donepezil HCl tablets) for treatment of severe Alzheimer's disease. Aricept is currently approved for treatment of mild to moderate AD.
The August 31 submission is based on clinical trial data of patients with severe AD. from approximately 250 nursing homes.
The study found that patients with severe AD (Mini Mental State Examination scores 1-10) treated with Aricept had a statistically significant improvement compared to those taking placebo in cognition and functioning.
www.alzinfo.org/newsarticle/anmviewer.asp?a=188&z=8
Alzheimer's Drug Aricept May Have Benefit in Severe Alzheimer's Disease
www.fda.gov/bbs/topics/NEWS/2006/NEW01491.html
FDA News - October 13, 2006
FDA Approves Expanded Use of Treatment for Patients
With Severe Alzheimer's Disease
The U.S. Food and Drug Administration (FDA) approved Aricept (donepezil hydrochloride) for the treatment of severe dementia in patients with Alzheimer's disease on Friday.
Aricept was previously approved for the treatment of mild to moderate dementia of the Alzheimer's type. It now becomes the first product approved for the treatment of all degrees of severity of the disease.
The FDA approved Aricept to treat patients with mild to moderate Alzheimer's disease ten years ago after two clinical trials demonstrated that patients receiving the drug performed better than patients who received a placebo. Today's approval is based on two additional clinical studies conducted in Sweden and Japan involving more than 500 patients with severe Alzheimer's disease. (snip)
www.medicalnewstoday.com/medicalnews.php?newsid=54267
U.S. Food And Drug Administration Approves ARICEPT(R) For Treatment Of Severe Alzheimer's Disease
Aricept has been officially approved for severe Alzheimers.
Background - the original approval was based on 6 month trials and was approved for mild to moderate alzheimers. Based on the trials, People often would believe that aricept only worked for 6 months and some insurance companies would approve Aricept only for six months.
Later, aricept ads would cite a study that aricept provided benefits for up over 5 years.
I also have seen a few posts were people with late stage alzheimers developed swallowing problems shortly after discontinuing aricept.
Now comes word that Aricept has been formally approved for severe Alzheimers.
ARICEPT FOR TREATMENT OF SEVERE ALZHEIMER'S (submitted)
September 6, 2005
(Source: Medical News Today) – Eisai Medical Research has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration for Aricept® (donepezil HCl tablets) for treatment of severe Alzheimer's disease. Aricept is currently approved for treatment of mild to moderate AD.
The August 31 submission is based on clinical trial data of patients with severe AD. from approximately 250 nursing homes.
The study found that patients with severe AD (Mini Mental State Examination scores 1-10) treated with Aricept had a statistically significant improvement compared to those taking placebo in cognition and functioning.
www.alzinfo.org/newsarticle/anmviewer.asp?a=188&z=8
Alzheimer's Drug Aricept May Have Benefit in Severe Alzheimer's Disease
www.fda.gov/bbs/topics/NEWS/2006/NEW01491.html
FDA News - October 13, 2006
FDA Approves Expanded Use of Treatment for Patients
With Severe Alzheimer's Disease
The U.S. Food and Drug Administration (FDA) approved Aricept (donepezil hydrochloride) for the treatment of severe dementia in patients with Alzheimer's disease on Friday.
Aricept was previously approved for the treatment of mild to moderate dementia of the Alzheimer's type. It now becomes the first product approved for the treatment of all degrees of severity of the disease.
The FDA approved Aricept to treat patients with mild to moderate Alzheimer's disease ten years ago after two clinical trials demonstrated that patients receiving the drug performed better than patients who received a placebo. Today's approval is based on two additional clinical studies conducted in Sweden and Japan involving more than 500 patients with severe Alzheimer's disease. (snip)
www.medicalnewstoday.com/medicalnews.php?newsid=54267
U.S. Food And Drug Administration Approves ARICEPT(R) For Treatment Of Severe Alzheimer's Disease
