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The Medicines Patent Pool Welcomes First Generic Dolutegravir-Combination to Receive Tentative Approval from U.S. Food and Drug Administration

Август 08, 2017

The Medicines Patent Pool (MPP) welcomes its sublicensing partner Mylan’s announcement yesterday that it has received Tentative Approval from the U.S. Food and Drug Administration (USFDA) for generic versions of its combination product tenofovir disoproxil fumarate (TDF), lamivudine (3TC) and dolutegravir (DTG).

Mylan signed a licence with the MPP for ViiV Healthcare’s dolutegravir in July 2014, and is the first company to receive USFDA approval for the DTG-combination product, a significant advancement in HIV therapy.

TDF and 3TC are part of the World Health Organization (WHO)’s preferred first-line treatment regimen for adults, while DTG is a promising new antiretroviral, recommended by the WHO as an alternative first-line medicine. A once-daily, single-tablet treatment, TDF/3TC/DTG is potentially less expensive, better tolerated, and has a higher barrier to resistance than current efavirenz-based first-line regimens.

“The MPP is pleased with Mylan’s rapid development and registration of this crucial option for developing countries,” said Greg Perry, Executive Director of the Medicines Patent Pool. “The world’s first combination of TDF/3TC/DTG can greatly improve standard of care in countries and we hope that local regulatory authorities will support its rollout through swift registration.”

In April 2014, ViiV Healthcare granted MPP licences for the generic manufacture of DTG for adults and children. The licences permit generic pharmaceutical companies based anywhere in the world to manufacture DTG and to combine the treatment with other drugs to develop fixed-dose combinations. In the spring of 2016, the two parties extended the adult licence to all lower middle-income countries, allowing sale of generic DTG in more than 130 countries. Thirteen MPP sublicensing partners are developing DTG as a standalone and in combination. Four have filed with USFDA, while three are seeking WHO Prequalification.