FDAnews Drug Daily Bulletin

GSK and ViiV Healthcare Use $130 Million Priority Review Voucher to Expedite HIV Therapy

June 9, 2017

GlaxoSmithKline and ViiV Healthcare redeemed a priority review voucher for their application for a single-tablet antiretroviral regimen of Tivicay (dolutegravir) and Edurant (rilpivirine) for maintenance treatment of HIV-1 infections. The voucher allows for an expedited six-month review — cutting four months from the standard review.

The transferrable priority review vouchers are awarded by the FDA following the approval of medicines aimed at rare pediatric diseases, tropical diseases and national security threats.

The companies recently acquired the voucher for $130 million, but did not disclose the seller. The vouchers have sold for as much as $350 million, as when AbbVie purchased one from United Therapeutics in August 2015.

The agency recently issued vouchers to Marathon and Sarepta, for their Duchenne muscular dystrophy medications, as well as to BioMarin and Biogen. Sarepta sold its voucher to Gilead, the company’s third, in February for $125 million.

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