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Misleading Claims

Genentech presents the claim “Nutropin Depot represents a significant advance in terms of convenience over other currently available growth hormone replacement therapies.”_ This claim is misleading because it implies comparable efficacy to daily growth hormone therapies along with the increased convenience of a once or twice monthly regimen. This implication is misleading because it does not convey the material information provided in the approved product labeling (Pl) that growth rates for the long-acting formulation may not be comparable to those achieved with the daily formulation. Historical studies showed growth rates achieved on daily therapy are higher for treatment-naive patients._ Also, according to the Pl, patients previously treated with daily growth hormone who were switched to Nutropin Depot experienced a decrease in growth rate._ This decrease was of a higher magnitude than could be accounted for by the normal decrease experienced by patients who remain on a daily regimen.



The claim that Nutropin Depot is “the first long-acting dosage form of somatropin” is misleading because it implies a greater usefulness than has been demonstrated by substantial evidence._ Nutropin Depot is only indicated for the long-term treatment of growth failure due to a lack of adequate endogenous GH secretion._ Because there are other forms of somatropin that are approved for additional indications, this claim misleadingly implies that Nutropin Depot can be used in place of any other somatropin for any other indication.