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Home Industry News GlaxoSmithKline/Pfizer joint venture’s HIV drug given priority review

GlaxoSmithKline/Pfizer joint venture’s HIV drug given priority review

19th February 2013

GlaxoSmithKline and Pfizer's joint venture ViiV Healthcare has announced that its innovative new therapy for HIV is to be fast-tracked through its US approval process.

The US Food and Drug Administration (FDA) has given the new treatment dolutegravir priority review status, a designation provided for compounds that have the potential to offer significant improvement compared to marketed products, or provide a new option where no adequate therapy exists.

Dolutegravir is under review as a treatment of HIV infection, in combination with other antiretroviral agents, in adults and adolescents, with evidence from four phase III clinical trials supporting the application.

The organisation also submitted a marketing authorisation application to the European Medicines Agency pertaining to the drug in December 2012.

Dr John Pottage, chief scientific and medical officer at ViiV Healthcare, previously stated that these moves demonstrate "our commitment as a company to bring new treatments to people living with HIV".

ViiV Healthcare is a global specialist HIV company and was established by GlaxoSmithKline and Pfizer in November 2009.ADNFCR-8000103-ID-801542609-ADNFCR

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