Positive CHMP opinion for Gilead’s Descovy
pharmafile | February 26, 2016 | News story | Research and Development |Â Â Gilead SciencesÂ
The Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the EMA, has adopted a positive opinion on Gilead Sciences’ HIV-1 drug Descovy (Emtriva and tenofovir alafenamide) (TAF), putting in on the path to full EU approval. The CHMP recommends the use of Descovy in combination with other HIV antiretroviral agents.
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 own Viread (tenofovir disoproxil fumarate, TDF). The company sees TAF regimens as the future of its infectious disease treatments, as TAF has been shown to enter cells more effectively than TDF, and so can be given at much lower doses, reducing the risk of side effects.
The CHMP’s recommendation will now be reviewed by the European Commission, which is likely to approve the drug for use in European Union member states.
Meanwhile, Gilead also announced that EMA has accepted its Marketing Authorization Application (MAA) for TAF to treat chronic hepatitis B virus (HBV) infection.
Phase III trial data show TAF-based regimens are as effective as TDF-based ones at supressing viral loads, with more favourable safety profiles.
“Chronic hepatitis B is a major health concern in Europe, with 14 million people living with the life-threatening disease and over 1 million Europeans newly infected with the virus each year,” says Norbert Bischofberger, executive vice president, Research and Development and chief scientific officer, Gilead Sciences. “The validation of this application represents the latest step in our continued efforts to advance the care of people living with progressive liver diseases like HBV.”
Joel Levy
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