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Released by FDA: 5/1/01.  Posted by FDA:  5/15/01

Barry Reit, Ph.D. 
Vice President, Regulatory Affairs 
Novo Nordisk Pharmaceuticals, Inc. 
100 College Road 
West Princeton, NJ 08540

RE:     Prandintm (repaglinide) Tablets 
           NDA 20-741 
           MACMIS ID#9997

Dear Mr. Reit:

This letter concerns several promotional materials (sales aid 124518; professional exhibit panels 124597; and posters 124421A, 124421C, l24421E) for Prandin (repaglinide) disseminated by Novo Nordisk Pharmaceuticals, Inc. (NNPI).   As part of its monitoring program, the Division of Drug Marketing, Advertising and Communications (DDMAC) has reviewed these promotional materials and has concluded that they are false or misleading, in violation of the Federal Food, Drug, and Cosmetic Act (Act) and its implementing regulations.   Our specific objections follow.

Minimizing Risk of Hypoglycemia

In sales aid 124518, poster 124421E, and exhibit panels 124597, you present statements such as “Prandin offers unique safety advantages,” “Low risk of severe hypoglycemia,” and “Lower risk of hypoglycemia vs glyburide, even when a meal is missed” along with a graphic that patients treated with Prandin experienced a 0% incidence of hypoglycemic events in a skip-a-meal study.   However, according to the Adverse Reactions section of the approved product labeling (PI), hypoglycemia occurred in 31% of Prandin-treated patients in placebo-controlled trials.   This fact is not presented in your materials.   The PI also states that in active controlled trials, “Mild or moderate hypoglycemia occurred in 16% of Prandin patients....”   Moreover, the PI states that 13% of Prandin treated patients discontinued Prandin treatment due to adverse events over one year, and the most common adverse events leading to withdrawal were hyperglycemia, hypoglycemia, and related symptoms.  Your disclosure that 16% of patients on Prandin experienced mild to moderate hypoglycemia on the bottom of poster 124421E and the exhibit panels, in extremely small type, fails to correct the misleading suggestion that Prandin is either not associated with hypoglycemia or has a low incidence of hypoglycemia. Your minimization of this known risk is particularly concerning since the potential risks associated with hypoglycemia raise significant safety concerns.

In sales aid 124518, you state “Neutral effect on weight: no clinically significant effect on weight in long-term clinical trials.”  This statement is misleading because it is inconsistent with the PI, which states, “The average weight gain in patients treated with Prandin and not previously treated with sulfonylurea drugs was 3.3%.”

Broadened Indication

In sales aid 124518 and poster 12442lA, you present statements such as “In type 2 diabetes beware PPG spike can threaten cardiovascular health,” “In type 2 diabetes the added burden of high mealtime glucose loads: Cardiovascular risk,” and “As postprandial glucose levels increase, so do cardiovascular risks.”   In addition, you present a graph depicting an increased incidence of mortality and myocardial infarction with increasing levels of postprandial glucose.   According to your PI, “Prandin is indicated as an adjunct to diet and exercise to lower the blood glucose in patients with type 2 diabetes mellitus (NIDDM) whose hyperglycemia cannot be controlled satisfactorily by diet and exercise alone.   Prandin is also indicated for use in combination with metformin to lower blood glucose in patients whose hyperglycemia cannot be controlled by exercise, diet, and either repaglinide or metformin alone.” Therefore, these presentations are misleading because they suggest that Prandin is indicated to reduce cardiovascular morbidity and mortality, when such has not been demonstrated by substantial evidence. 

Unsubstantiated Superiority Claims

Promotional materials are misleading if they suggest that a drug is superior to other products when such has not been demonstrated by substantial evidence.   In poster 12442W and sales aid 124518, you present prominent headers such as “Prandin offers unique safety advantages,” “Choose Prandin instead of a sulfonylurea,” and “The Prandin advantage” along with a comparison of the profile of Prandin and selected oral sulfonylureas.   These presentations are misleading because they imply that Prandin is superior to the sulfonylureas, when such has not been demonstrated by substantial evidence.

Requested Action

NNPI should immediately discontinue these and all other promotional materials for Prandin that contain the same or similar claims or presentations.   We request that NNPI respond, in writing, with its intent to comply with the above.    DDMAC should receive your written response no later than May 15, 2001.    This response should list all similarly violative materials with a description of the method for discontinuation and the discontinuation date.

If you have any questions or comments, please contact me by facsimile at (301) 594-6771, or at the Food and Drug Administration, Division of Drug Marketing, Advertising and Communications, HFD- 42,   Rm.17B-20, 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 #9997 in addition to the NDA number.

Sincerely,

Barbara S. Chong, Pharm.D., BCPS 
Regulatory Review Officer 
Division of Drug Marketing, 
      Advertising and Communications

 

 

 

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