Priority to review for Gilead, its new drugs of AIDS is expected to accelerate to list

  • Author:Jane
  • Source:ZHIYAO
  • Release on :2017-08-17
Gillead Sciences recently announced that the US FDA has granted its HIV infection cocktail therapy bictegravir and emtricitabine / tenofovir alafenamide (FTC / TAF) priority review qualification, is expected no later than February 12, 2018 to make a decision.

The therapy is a fixed dose of a single tablet regimen containing 50 mg of integrated enzyme chain transfer inhibitor bictegravir (BIC) and 200 mg / 25 mg of FTC / TAF backbone for HIV-1 infected treatment. Gilead filed a new drug application for the therapy with FDA in June of this year and received a priority review.

The new drug application is based on its three clinical trials of excellent data. These data are derived from four separate studies, both of which demonstrate that the cocktail therapy has a high rate of viral suppression and is not inferior to the treatment regimen of 50 mg of dolutegravir (DTG) in the treatment of newly diagnosed patients, The main end point.

"Since 16 years ago Viread has been approved, Gilead continues to work hard to develop and improve the treatment of HIV patients. This monotherapy solution combines the efficacy of the integrase inhibitor bictegravir with the proven FTC / TAF backbone And security together, "said Norbert Bischofberger, chief scientific officer of Gilead.
In addition to seeking US FDA approval, Gilead Sciences is also seeking approval from the European Medicines Agency (EMA) for BIC / FTC / TAF therapy.

It is worth mentioning that this month the US FDA approved the Gilead drug Epclusa extended indications for the treatment of HCV and HIV co-infected adult patients.

We are looking forward to the approval of this cocktail therapy to bring new treatment options to people living with HIV.