FDA Additional Indication Approval For Gardasil® Won’t Move Needle


While this was something Whitehouse Station was actively pursuing, most analysts know it won’t move the needle (much) — on US Gardasil® sales. Per tonight’s presser, then:

. . . .In the United States, an estimated 75 to 80 percent of males and females will be infected with HPV in their lifetime. For most, HPV will clear on its own. However, for those who don’t clear certain types, HPV can cause cervical, vaginal and vulvar cancers in women and anal cancer and genital warts in men and women. There is no way to predict who will or won’t clear the virus.

Gardasil helps protect against the four types of HPV, specifically types 6, 11, 16, and 18, that cause the most disease. . . .

Good news, to be sure — but (arguably) not material, or only barely material. I think Merck (in a joint venture with CSL) is still awaiting regulatory approval for this indication, in Australia.

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