Two years after swallowing a rejection from the FDA for insufficient data for its human papillomavirus vaccine, GlaxoSmithKline received the support of the agency's expert advisers today. GlaxoSmithKline has been seeking approval to market Cervarix to women ages 10 to 25. The panel voted overwhelming that new Cervarix data demonstrated that the vaccine was both safe and effective at preventing HPV. Which means Merck's Gardasil will see major competition very soon.
In a preliminary review, FDA staffers had expressed concerns regarding the risk of miscarriages and inflammatory-muscular problems but experts said today that it was unlikely those problems were related to the vaccine. However, the group said the risks should be noted on the product's label and at-risk patients should be monitored.
Cervarix is already approved in over 100 other countries, but Gardasil has had a tight hold on the U.S. market since it was approved in 2006. And Merck is seeking to expand its market base with a new indication for young males. That vote is also expected today.