GSK wins China FDA's first HPV approval with Cervarix vaccine

GlaxoSmithKline ($GSK) has received the first China FDA marketing authorization approval for a human papillomavirus (HPV) vaccine, with Cervarix scheduled for a launch early next year.

In a release, GSK said the vaccine is registered for women ages 9 to 25 using a three-jab schedule.

Merck ($MRK), maker of the HPV vaccine Gardasil, and GSK face the prospect of convincing more doctors to recommend the inoculations to younger patients in Asia, with the same case in the U.S. where public campaigns have highlighted potential risks of related cancers to boys and girls later in life.

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The approval for GSK in China is also notable for a continued rapprochement with Chinese regulators following a nearly $500 million fine levied in late 2014 for paying bribes to boost drug sales.

For its part, GSK has moved to revamp its sales structure and has engaged in detailed talks on pricing and access with policymakers for therapies to treat HIV/AIDs and hepatitis B.

That has helped the company get into provincial and national drug lists that aid volume sales, a strategy it intends to pursue with Cervarix, though details were not available.

"To achieve this we are ready to explore an innovative pricing approach to support the inclusion of Cervarix into public cervical cancer immunization programs," Hervé Gisserot, senior vice president of pharmaceuticals and vaccines, GSK China/Hong Kong, said in a statement seen by Reuters.

In a further nod to the government, GSK said in the release that it fully supports new regulations on vaccine distribution in China implemented in the wake of a scandal that saw expired and improperly stored vaccines worth $88 million illegally sold by a network allegedly helmed by a mother and daughter over several years.

- here's the GSK release (Chinese language)
- here's the story from Reuters

Related Articles:
Merck's Gardasil leads to major HPV declines, but coverage holes remain: Study
Busy Takeda transfers HPV vaccine candidate to research institute for development


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