Glaxo still in talks with FDA about Cervarix

Share this article:
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.
Share this article:
You must be a registered member of MMM to post a comment.
close

Next Article in Business Briefs

Email Newsletters

More in Business Briefs

Apple selfies spur diabetes donations

Jazz apples has launched a Crunch to Contribute campaign to raise money for one of two diabetes associations.

Baxter seeks Cambridge, Mass. HQ

Illinois may be tempted to offer tax incentives for the firm to stay put.

FDA wants Alexion to clean up

FDA inspectors have cited the manufacturer of the rare-disease drug Soliris (eculizumab) for poor manufacturing practices.