Gilead’s next-generation HIV drug to be FDA assessed
pharmafile | April 8, 2015 | News story | Research and Development, Sales and Marketing | F/TAF, FDA, Gilead, HIV, Tenofovir Alafenamide, emtricitabine
Gilead Sciences has filed its second new drug application for a new combination HIV treatment with the FDA.
The California-based company submitted for review its investigational HIV treatments – two fixed-dose combinations of two Gilead drugs, emtricitabine and tenofovir alafenamide (F/TAF), for the treatment of HIV-1 infection in adults and children aged 12 years and older.
F/TAF is a novel nucleotide reverse transcriptase inhibitor (NRTI), and late stage trials have found F/TAF is no less effective than an existing Gilead HIV treatment, Stribild (elvitegravir cobicistat tenofovir emtricitabine).
In clinical trials the TAF combination has also shown high antiviral efficacy at a dose less than one-tenth that of Gilead’s Viread (tenofovir disoproxil fumarate, TDF), as well as better renal and bone safety compared to TDF.
Today’s filing is the second F/TAF combination Gilead has submitted to the FDA for review, in November 2014 it filed an NDA for an investigational once-daily single tablet regimen containing elvitegravir, cobicistat, emtricitabine and TAF 10 mg (E/C/F/TAF), and a decision is set for November this year. In the EU Gilead earned approval for this in December last year.
“Gilead has a long history of innovating HIV treatments, and with F/TAF we have the potential to further optimise therapies for HIV patients who face a lifetime of antiretroviral treatment,” says Norbert Bischofberger, executive VP of R&D and chief scientific officer at Gilead.
“With its high antiviral efficacy and favourable safety profile, F/TAF may offer an improved backbone for a new generation of HIV regimens.”
Gilead plans to submit a regulatory application for F/TAF in the European Union in the second quarter of 2015.
Lilian Anekwe
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