Merck wins FDA approval for Gardasil follow-up
On Wednesday, the FDA approved Gardasil 9, which prevents cervical, vulvar, vaginal and anal cancers caused by the four HPV types its predecessor protects against, as well as an additional 5 types--31, 33, 45, 52 and 58--that cause approximately one-fifth of cervical cancers, according to the FDA.
In a study of approximately 14,000 females ages 16 through 26, Gardasil 9 proved as effective as Gardasil at blocking the four shared HPV types, and researchers determined it was 97% effective in preventing cancers caused by the 5 additional types.
While analysts estimate the new vaccine could rake in $1.9 billion a year at its peak, much of its potential market share will come at Gardasil's expense. Leerink has estimated the old vaccine will sink to just $525 million in 2018 sales for the New Jersey pharma giant--a far cry from last year's $1.83 billion tally.
But Merck may be able to amp up Gardasil 9's haul if it can overcome some of the uptake issues that have been plaguing the original shot since it hit the market. A variety of factors, including sex-related stigma, have weighed on sales, leading analysts to revise Gardasil sales predictions that once reached as high as $10 billion.
On that front, however, the company got some good news earlier this week: In a study of teen girls, HPV vaccination didn't lead to an increase in risky sexual activity, a new study showed.
- read the FDA's release
- get more from Reuters on the HPV study
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