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November 6, 2015
| Japan Tobacco Inc. |
| Torii Pharmaceutical Co., Ltd. |
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Novel anti-HIV drug Genvoya® received US regulatory approval,
JT’s partner Gilead Sciences announced
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A New Drug Application for once-daily single tablet regimen Genvoya® (elvitegravir 150mg, cobicistat 150mg, emtricitabine 200mg and tenofovir alafenamide (TAF) 10mg) for the treatment of HIV-1 infection has been approved by the U.S. Food and Drug Administration (FDA). Genvoya is the first TAF-based regimen to receive FDA approval. Japan Tobacco Inc. (JT) (TSE:2914) and Torii Pharmaceutical Co., Ltd. (Torii) (TSE:4551) announced that a statement has been issued to this effect by Gilead Sciences, Inc. (Gilead) on November 5, 2015, the U.S. local time.
Genvoya is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least six months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Genvoya. No dosage adjustment of Genvoya is required in patients with estimated creatinine clearance greater than or equal to 30 mL per minute.
TAF is a novel targeted prodrug of tenofovir that has demonstrated high antiviral efficacy similar to and at a dose less than one-tenth that of Gilead’s Viread® (tenofovir disoproxil fumarate, TDF), as well as improvement in surrogate laboratory markers of renal and bone safety as compared to TDF in clinical trials in combination with other antiretroviral agents. Data show that because TAF enters cells, including HIV- infected cells, more efficiently than TDF, it can be given at a lower dose and there is 91 percent less tenofovir in the bloodstream.
Following a positive opinion by the scientific committee of the European Medicines Agency, Genvoya is now under review by the European Commission. In addition to Genvoya, another investigational, TAF-based, fixed-dose combination of emtricitabine 200 mg and tenofovir alafenamide 25 or 10 mg (F/TAF) for use in combination with other antiretroviral agents is also under evaluation by the FDA and the European Medicines Agency.
JT holds the exclusive rights to develop and commercialize Genvoya and F/TAF in Japan, and the Company is aiming to submit a New Drug Application for Genvoya in the first quarter of FY2016, to the Japanese Ministry of Health, Labour and Welfare.
Under the terms of the agreement between JT and Torii on March 2, 2015, Torii holds exclusive rights to market Genvoya and F/TAF in Japan, subsequent to JT’s obtaining manufacturing and marketing approval from the country’s authorities.
*Elvitegravir was discovered by JT. The Company licensed elvitegravir to Gilead in 2005 with exclusive rights to develop and commercialize in all countries of the world, excluding Japan, where JT retains rights.
*TAF and TAF-based regimens are investigational products and have not been determined safe or efficacious in Japan.
*Genvoya and Viread are registered trademarks of Gilead.
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