GlaxoSmithKline says that the European Commission has approved its cervical cancer vaccine Cervarix, which means that the jab can now compete with Merck & Co’s Gardasil.
Cervarix is indicated for the prevention of precancerous cervical lesions and cervical cancer causally related to human papillomavirus types 16 and 18 in girls and women aged between 10 and 25. The approval is based on data from clinical trials in almost 30,000 females, including data from the largest Phase III cervical cancer vaccine efficacy trial to date, involving more than 18,600 women. The results showed that Cervarix was almost 100% effective in preventing precancerous lesions caused by HPV 16 and 18.
The GSK jab now has some catching-up to do on already-marketed Gardasil which is sold in Europe by Merck via a vaccine joint venture with Sanofi-Aventis. Both vaccines employ the use of adjuvants, which boost the ability of an antigen to stimulate an immune response but while Gardasil uses an aluminum salt adjuvant, Cervarix uses a novel adjuvant known as AS04, which GSK is hoping will give its vaccine an edge.
Cervarix was approved in Australia in May but is unlikely to be sold on the all-important US market before next year. A file was only submitted to the Food and Drug Administration in March and the agency declined to give the vaccine a fast-track review on the basis that it does not meet a major unmet medical need or offer a significant advance on current therapy.
FDA issues approvable letter on Lamictal XR
The good news about Cervarix was a boost for GSK as it came just after the FDA only issued an approvable letter for a new extended-release version of the anti-epileptic blockbuster Lamictal (lamotrigine).
Lamictal XR is a once-daily formulation which is currently taken twice daily by most epilepsy patients and had second-quarter sales of £271 million, though it is facing generic competition in Europe. Its US patents will soon run out as well hence the desire to get Lamictal XR on the market as soon as possible.
However GSK is going to have to wait and limited itself to saying that it is committed to working with the FDA “to address any questions they have and evaluate the best way forward”.