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 women. Glaxo has said it believes the total cervical cancer vaccine market may be worth $4 billion to $7 billion in annual sales by 2010.