ACCELERATED APPROVAL SOUGHT BY GSK FOR INVESTIGATIONAL AVIAN FLU VACCINE

British drugmaker GlaxoSmithKline (GSK) has joined the list of drug companies pursuing development of an avian flu vaccine, announcing late last week it plans to unveil initial clinical study results for its investigational vaccine in next year second quarter.

GSK vaccine would allow for treatment at lower doses by using an alum adjuvant designed to increase the body immune response to the vaccine, the firm said. The low-dose formulation would result in a greater supply capacity in the event of a pandemic, GSK added.

The company is currently working with the FDA to accelerate the approval process, GSK spokeswoman Patty Seif said. In the European Union, GSK uses a ;mock filing; that allows it to provide regulators with initial clinical trial data and manufacturing information, so that if an emergency arises it is easier to introduce the treatment. The company is attempting to use a similar strategy for its vaccine in the U.S., Seif said.

The FDA announced last week that it had formed a ;Rapid Response Team to help remove roadblocks that might delay development of pandemic vaccines. Among other goals, the response team will support clinical studies to test new potential treatments and may allow such new medications to be available under an Emergency Use Authorization, which could enable new vaccines could be approved within eight weeks. Other drugmakers developing avian flu vaccines include sanofi-aventis and Chiron. Sanofi-aventis signed a $100-million contract with the HHS earlier this year, and Chiron was recently awarded a similar contract, valued at $62.5 million.