January 06, 2006
Glaxo still in talks with FDA about Cervarix
GlaxoSmithKline said this week it was in discussions with the FDA about its
Cervarix cervical cancer vaccine and hoped to issue soon an update on
submitting the drug for approval, Reuters reported.
Glaxo had previously planned to announce a timetable for filing Cervarix with
the FDA before the end of 2005.
“Discussions with the FDA are progressing, and we expect to be able
to give an update soon,” a spokesman told Reuters.
Cervarix is viewed as one of the most important new medicines in
Glaxo’s pipeline. However, the drug appears set to reach the market
behind Merck’s similar vaccine Gardasil, which has already been
submitted for US and European approval.
Industry analysts have been expecting Glaxo to file in the US
sometime in 2006. Most say a first-half submission would be viewed
as positive, whereas any delay into 2007 would be seen as negative.
Both Cervarix and Gardasil have proved effective in clinical trials
in preventing strains of human papillomavirus, which causes most
cases of cervical cancer, the second-biggest cancer killer in
Glaxo has said it believes the total cervical cancer vaccine market
may be worth $4 billion to $7 billion in annual sales by 2010.