Gilead Sciences Inc. GILD announced that it has submitted a New Drug Application for tenofovir alafenamide (TAF), 25 mg, to Japan’s Pharmaceutical and Medical Devices Agency for the treatment of adults with chronic hepatitis B virus (HBV) infection.
The company stated that TAF, at a dose less than one-tenth of that of Viread, another Gilead drug, had demonstrated high antiviral efficacy similar to Viread. Viread is currently marketed in Japan by GlaxoSmithKline plc GSK as Tenozet. In 2015, Viread sales increased 4.7% to $1.1 billion.
According to information provided by the company, over one million individuals are infected with chronic HBV in Japan.
We note that TAF is currently under review in both the U.S. and the EU for the same indication.
We remind investors that in Nov 2015, Gilead’s first TAF-based regimen, Genvoya, was approved by the FDA for the treatment of human immunodeficiency virus-1 (HIV-1) infection. Genvoya comprises TAF, Vitekta (elvitegravir), Tybost (cobicistat) and Emtriva (emtricitabine). Genvoya recorded sales of $45 million in the fourth quarter.
Moreover, early last month, the FDA approved the company’s second TAF-based regimen, Odefsey, for the treatment of HIV-1 infection in certain patients.
Meanwhile, in Feb 2016, the company received a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency for Descovy, which comprises Emtriva and TAF, for the treatment of HIV-1 infection in patients aged above 12 years with body weight of at least 35 kg, in combination with other HIV antiretroviral agents.
The company stated that TAF, at a dose less than one-tenth of that of Viread, another Gilead drug, had demonstrated high antiviral efficacy similar to Viread. Viread is currently marketed in Japan by GlaxoSmithKline plc GSK as Tenozet. In 2015, Viread sales increased 4.7% to $1.1 billion.
According to information provided by the company, over one million individuals are infected with chronic HBV in Japan.
We note that TAF is currently under review in both the U.S. and the EU for the same indication.
We remind investors that in Nov 2015, Gilead’s first TAF-based regimen, Genvoya, was approved by the FDA for the treatment of human immunodeficiency virus-1 (HIV-1) infection. Genvoya comprises TAF, Vitekta (elvitegravir), Tybost (cobicistat) and Emtriva (emtricitabine). Genvoya recorded sales of $45 million in the fourth quarter.
Moreover, early last month, the FDA approved the company’s second TAF-based regimen, Odefsey, for the treatment of HIV-1 infection in certain patients.
Meanwhile, in Feb 2016, the company received a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency for Descovy, which comprises Emtriva and TAF, for the treatment of HIV-1 infection in patients aged above 12 years with body weight of at least 35 kg, in combination with other HIV antiretroviral agents.
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