GSK submits Cervarix BLA to US FDA

UK drug major GlaxoSmithKline has sumbitted a data package on its cervical cancer vaccine Cervarix to the US Food and Drug Administration, ahead of its second quarter target filing date. If licensed, the vaccine will also be indicated for the prevention of pre-cancerous lesions associated with the most common cancer-causing human papillomavirus types. For this candidate vaccine, GSK selected a novel proprietary adjuvant system called AS04, intended to enhance immune response, as well as to increase the duration of protection.

In a note to investors, Evolution Securities analyst Peter Cartwright said that "GSK is so confident for this vaccine that a head-to-head trial against [Merck & Co's] equivalent and first-to-market product Gardasil (which had fourth quarter sales of $155.0 million) is already planned." He estimates that the global market for HPV vaccines is worth around L2.0-L4.0 billion.

GSK's Biologics License Application for Cervarix includes data from clinical trials in almost 30,000 females aged between 10 and 55 years. The submission also contains data from the largest Phase III cervical cancer vaccine efficacy trial to date, conducted in over 18,000 women.