GSK Receives Priority Status For New HIV Drug
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