Gilead Submits NDA For Tenofovir Alafenamide Combination For HIV
By Cyndi Root
Gilead Sciences has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for a tenofovir alafenamide (TAF) combination to treat HIV. The single tablet contains elvitegravir, cobicistat, emtricitabine, and TAF (E/C/F/TAF). Gilead announced the NDA in a press release, stating that it is the first of many TAF regimes it is pursuing.
Norbert Bischofberger, PhD, Executive VP of Research and Development at Gilead Sciences, said, “This TAF-based regimen has the potential to provide a range of HIV patients with a highly effective and well-tolerated new treatment option with a favorable safety profile. TAF will be the cornerstone of future Gilead single tablet regimens.”
Tenofovir Alafenamide
The NDA for tenofovir alafenamide is for the treatment of HIV-1 infection in adults, although Gilead’s data supporting the NDA includes adults and adolescents. TAF is a prodrug of tenofovir, but displays better targeting, higher antiviral efficiency, a 10 times lower dose, and a better safety profile. The TAF combination has been tested in treatment-naïve patients, virologically suppressed patients who switch regimens, and patients with renal impairment. Gilead states that it will file in the European Union for regulatory approval of the TAF combination by the end of 2014.
NDA Studies
Gilead is supporting its NDA for the E/C/F/TAF agent by two Phase 3 studies performed over 48 weeks. Studies 104 and 111 met their primary objectives, showing that the TAF combination was non-inferior to Gilead’s Stribild. Additionally, and of importance to Gilead VP Norbert Bischofberger who says that safer drugs are important because patients are living longer, the studies show that the TAF combination has a better renal and bone safety profile. Gilead has also provided Chemistry, Manufacturing, and Controls (CMC) information on the components in the treatment and the formulation of the single tablet regimen.
Gilead Licenses Tenofovir Alafenamide
Gilead announced in July 2014 that it had licensed tenofovir alafenamide to the Medicines Patent Pool (MPP). If the FDA approves Gilead’s NDA, the MPP is authorized to sub-license TAF to Chinese and Indian generic drug companies. Those companies in turn will be able to distribute it to 112 developing countries. Gilead joined the MPP in 2011, and the new agreement with MPP is an extension of an earlier agreement to join forces in providing low-cost, high-quality versions of TAF to developing countries.