Move Over Gardasil…Cervarix Backed By FDA
The FDA voted yesterday to endorse the new cervical cancer medication from GlaxoSmithKline, Cervarix.
Good news for GlaxoSmithKline, bad news for Merck.
Merck is the owner of Gardasil, the only cervical cancer vaccination that is currently available on the market.
According to MSNBC,
London-based drugmaker Glaxo already has won approval for its vaccine in Europe, but its U.S. launch was delayed in 2007 when the FDA said it needed more data about the vaccine.
Panelists say newer studies suggest the vaccine is safe, but they recommend follow-up studies to monitor miscarriages and inflammatory-muscular problems reported by a small number of patients.
The group said it was unlikely those problems were related to the vaccine, but said the issues should still be noted on the product labeling.
I am not so sure that the FDA was as concerned with the safety of the vaccine as they were with protecting Merck’s profits. Gardasil sales, which reached $1.5 billion in 2007 would have taken a huge hit.
Gardasil and Cervarix both defend against the two most prevalent strains of HPV 16 and 18. These two strains are responsible for 70 percent of cervical cancer cases.
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September 24th, 2009 at 10:25 pm
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September 25th, 2009 at 4:22 pm
gardasil also protects against HPV types 6 and 11 (which are responsible for genital warts) in addition to types 16 and 18. is there any circumstance when cervarix would be a better choice than gardasil? maybe its not about the FDA protecting Merck but about Merck putting out a superior product.