The US Food and Drug Administration has told Amgen to stop broadcasting a television advertisement for its lead psoriasis drug, Enbrel (etanercept), because it overstates the product’s effectiveness and minimises the risks associated with its use.
In a warning letter posted on its website on Friday, the FDA says that Enbrel has not been shown to completely clear psoriatic skin, even though the 12 patients in the 60-second TV ad seem to have no visible signs of psoriasis after using the drug. The agency also notes that the ad is misleading for claiming that Enbrel can dramatically clear skin “fast” – in reality, clinical response typically occurs after two months of treatment. It has also taken issue with Amgen for claiming Enbrel as “breakthrough” treatment. “Enbrel is not a breakthrough therapy for moderate to severe plaque psoriasis because it does not offer any documented material difference that offers a significant advantage over other drugs already available,” the warning letter stated.
In addition, the FDA says that the TV ad is misleading because it “fails to clearly communicate to consumers the risk-related limitations to the approved indication,” and suggests that Enbrel is useful in a broader range of conditions or patients than has actually been shown. Furthermore, the agency notes that the ad minimises some of the serious and even life-threatening side effects associated with Enbrel’s use, including serious infections and sepsis, and haematological events.