Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


GSK resubmits BLA for Cervarix

Executive Summary

Finally responding to a December 2007 "complete response" letter from FDA, GlaxoSmithKline has re-filed its BLA for Cervarix, its vaccine to prevent cervical cancer and pre-cancer related to human papillomavirus types 16 and 18. Cervarix is approved in Europe and is the market leader in the U.K., ahead of Merck's competing vaccine, Gardasil. GSK's new filing, announced March 30, includes final data from the pivotal HPV-008 study - the previous BLA was based upon interim data. Also holding up FDA approval was the fact that the vaccine uses an adjuvant that is new and has a new active ingredient for which the agency had no regulatory framework (1"The Pink Sheet" DAILY, Oct. 22, 2008)

Related Content

Glaxo Boasts Cervarix Protects Against Five Most Common HPV Strains
GlaxoSmithKline Looks To Revamp U.S. Operations In Tough Environment





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts