GSK Receives Priority Status For New HIV Drug

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GSK Receives Priority Status For New HIV Drug

Main Category: HIV / AIDS
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 16 Feb 2013

The experimental drug for HIV/AIDS, referred to as dolutegravir, received priority review status by U.S. FDA (Food and Drug Administration) officials.

Drugs are given priory status when the FDA believes they could possibly provide notable improvement over current treatments.

Dolutegravir is a GlaxoSmithKline (GSK) drug which has been thought of by manufacturing analysts as a potential multibillion-dollar-a-year seller.

The decision on wether to approve the HIV/AIDS drug will be made by August 17th, says GSK, Britain's largest drug maker.

The drug is meant to be taken once a day and belongs to a new class of medicines called integrase inhibitors.

The treatment is owned by ViiV Healthcare, a joint venture centered on HIV in which GSK is the biggest shareholder.

Viiv was set up in 2009 by GSK and Pfizer when they decided to combine their HIV/AIDS drug businesses into one company. GSK initially held 85% of the joint venture, while Pfizer held 15%.

The novel medication has shown positive results in clinical studies, which pushed GSK to redraw its contract with the Japanese drug maker Shionogi.

The agreement now states that Shionogi has a 10% stake in Viiv and will receive its shared rights to the new drug. It also states that GSK owns 76.5% of the joint venture, and 13.5% is owned by Pfizer.

Dolutegravir will be a tough competitor to Gilead Sciences' drugs, the most common treatments for HIV, industry specialists said.

Written by Sarah Glynn
Copyright: MediLexicon International Ltd

Original article posted on Medical News Today.
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