Released by FDA: 11/20/02. Posted by FDA: 11/26/02
Victoria M. Wagner-Weber
Assistant Director, Regulatory Affairs
Janssen Research Foundation
1125 Trenton-Harbourton Road
Titusville, New Jersey 08560-0200
Re: NDA 21-169
Reminyl (galantamine HBr)
MACMIS # 10722
Dear Ms. Wagner-Weber:
Through routine monitoring and surveillance, the Division of Drug Marketing, Advertising, and Communications (DDMAC) has identified promotional materials (01M-210, 01-RM-213) for Reminyl (galantamine HBr) that are misleading and in violation of the Federal Food, Drug, and Cosmetic Act and applicable regulations.
Specifically, DDMAC objects to the following:
- Claims or representations that Reminyl is safe and effective for the treatment of Alzheimer's patient subgroups with probable vascular dementia are misleading because they suggest a specific benefit linked to the vascular dementia when none has been demonstrated. Specifically, as all patients in the study relied on had Alzheimer's Disease for which Reminyl is effective, the fact that they also may have had another disease is not of clear relevance. Put another way, the patients should have responded to the Alzheimer's treatment whether or not they had another disease. The effectiveness of Reminyl for the claimed new use has not been demonstrated by substantial evidence or substantial clinical experience. Examples of the misleading claims include
 | a two-page spread in the slim jim detail aid (01-RM-213, pages 6-7)
entitled "New Data Available: Alzheimer's Disease with Cerebrovascular
Disease and Probable Vascular Dementia" presenting four graphs that
depict positive results in cognition, global function, activities of
daily living (ADLs), and behavior. |
| the front of a fact card (01-RM-210) and pages 2-3 of the slim Jim (O1-RM-213), entitled "All Around Benefits," that state that there were "2 patient types studied" with Reminyl. A -second bullet under this headline indicates that the second group includes "AD with cerebrovascular disease and probable vascular dementia" representing "82% of all dementia patients." An accompanying pie chart emphasizes the importance of this second group. |
The study referenced to support these claims (GAL-INT-6) is inadequate for several reasons. First, the patient population subgroups labeled "probable vascular dementia" and "cerebrovascular disease" (or "mixed dementia") have not been shown to be clinically distinct populations from Alzheimer's Disease. Second, apart from whether such a demonstration would have been meaningful, Reminyl did not in fact demonstrate efficacy in the "probable vascular dementia" subgroup. Evidence of efficacy was seen in the "mixed dementia" subgroup, but, as noted above, the co-existing Alzheimer's Disease in this subgroup may have accounted for all of the benefit seen in the study. As you know, [deleted] submitted a supplemental new drug application for [deleted] seeking [deleted].
- The front of the fact card and page 3 of the slim jim also state that Reminyl is a "unique agent with consistent results." This claim is misleading because it implies that Reminyl is distinct in its properties from other acetylcholinesterase inhibitors demonstrated to be safe and effective For the treatment of mild to moderate Alzheimer's disease. As new molecular entity, of course, galantamine has a unique structure. However, there are pharmacologically similar products that have the same indications.
To address these objections, DDMAC requests that Janssen do the following:
- Immediately discontinue the use of these and any other promotional
material or activities with the same or similar issues.
- Respond to this letter within ten days. Your response should include a statement of your intent to comply with the above, a list of all promotional materials and activities with the same or similar issues; and your methods for discontinuing their use.
If you have any questions or comments, please contact the undersigned by facsimile at (301) 5946771, or at the Food and Drug Administration, Division of Drug Marketing, Advertising and Communications; HFD-42, rm. 813-45, 5600 Fishers Lane; Rockville, MD 20857. DDMAC reminds you that only written communications are considered official.
In all future correspondence regarding this particular matter, please refer to MACMIS ID #10722 in addition to the NDA number.
Sincerely,
Lisa L. Stockbridge, Ph.D.
Regulatory Reviewer
Division of Drug Marketing,
Advertising and Communications
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